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RecruitingNCT07792226Updated Oct 19, 2026

ENLIGHT Trial: ESG With Fundal Mucosal Ablation

An interventional study of Endoscopic Sleeve Gastroplasty (ESG) and Fundal Mucosal Ablation in Obesity and Obesity (Body Mass Index >30 kg/m2), sponsored by West Virginia University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by West Virginia University · Not applicable, Interventional, and Treatment

Updated Oct 15, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone.

Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized on the procedure day to either ESG with FMA or standard ESG alone. The ENLIGHT Trial is a single-center, randomized controlled trial evaluating whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG) improves weight loss and metabolic outcomes in adults with obesity. ESG reduces stomach volume through endoscopic suturing, while FMA uses Hybrid Argon Plasma Coagulation to ablate ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and improving satiety. Because previous ESG with FMA studies were small and single-arm, this trial is designed to provide comparative evidence against ESG alone.

Eligible adults aged 18 years or older with a BMI of at least 30 kg/m² and a history of unsuccessful weight-loss attempts will be enrolled. Participants will be randomized 1:1 on the procedure day to either ESG with FMA or standard ESG alone. The primary outcome is the difference between groups in percentage total body weight loss at 12 months. Secondary outcomes include percent excess weight loss, fasting ghrelin levels, blood pressure and antihypertensive medication use, lipid profile, fasting glucose, insulin, HbA1c, insulin resistance, hepatic steatosis and fibrosis measures, quality of life, pain, gastric symptoms, appetite and eating behavior, and the frequency and severity of adverse events.

Read the detailed description

Obesity is associated with a number of chronic health conditions, including type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea, and metabolic liver disease. Treatment options include lifestyle modification, anti-obesity medications, bariatric surgery, and endoscopic weight-loss procedures.

ESG is an endoscopic procedure in which full-thickness sutures are placed to reduce the volume and length of the stomach and create a sleeve-like configuration. The gastric fundus is generally preserved during ESG. Although ESG has been shown to produce clinically meaningful weight loss, weight loss following ESG is generally less than that achieved with surgical sleeve gastrectomy.

One possible explanation for this difference is the role of the gastric fundus in appetite regulation. The fundus contains a large number of cells that produce ghrelin, a hormone involved in hunger and food intake. Procedures that remove or alter the gastric fundus may reduce circulating ghrelin levels. Fundal mucosal ablation (FMA) is an emerging endoscopic technique designed to treat the mucosal lining of the gastric fundus while preserving the stomach itself. Early studies have suggested that FMA may reduce fasting ghrelin levels and may contribute to reductions in hunger and body weight. The ENLIGHT trial is designed to determine whether adding FMA to standard ESG provides additional benefit compared with ESG alone.

Participants assigned to the ESG group will undergo standard ESG under general anesthesia. Participants assigned to the ESG with FMA group will undergo standard ESG together with FMA during the same procedure. Following the procedure, participants in both groups will receive similar standard post-procedure care. Participants will be followed for approximately 52 weeks after the procedure.

Study Significance

The ENLIGHT Trial is intended to provide comparative evidence regarding whether adding FMA to ESG improves weight loss while maintaining an acceptable safety and tolerability profile. The study will also help determine whether the combined procedure has additional effects on metabolic health, obesity-related conditions, patient-reported outcomes, and fasting ghrelin levels.

02

Conditions studied

  • Obesity
  • Obesity (Body Mass Index >30 kg/m2)

Keywords

  • Obesity
  • Diabetes Mellitus
  • MASH
  • Circulation Disorder
  • Diabetes Prevention
  • Type 2 Diabetes (Adult Onset)
  • Vascular Disease
  • Liver Diseases
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 62 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

West Virginia University is the lead sponsor of 157 studies on the registry; 36 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Browse West Virginia University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female subjects aged ≥18 years
  2. Subjects with a ≥30 kg/m²
  3. Subjects have a history of failure of at least one prior weight loss attempt, including but not limited to dietary modification, physical exercise, behavioral modification, pharmacologic therapy (alone or in combination), or other non-surgical weight reduction methods.
  4. Willing and able to comply with all study requirements, including but not limited to signing a written form prior to participation, routine follow-up visit schedule, completing all required laboratory, imaging, and additional assessments, and participating in dietary counseling sessions.
  5. Women of (i.e., not and not surgically sterilized) must agree to use adequate and effective methods throughout the study period.
  6. Able to travel to visit the study site and have access to the internet to facilitate remote follow-up activities, as applicable.

Exclusion criteria

Exclusion Criteria:

  1. Prior gastric or bariatric surgery/procedure that may affect the anatomy or feasibility of the intervention, (e.g; prior Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, endoscopic sleeve gastroplasty).
  2. structural abnormality that may increase procedural risk or interfere with endoscopic access
  3. Conditions associated with increased bleeding (e.g., severe coagulopathy, severe immunocompromise).
  4. Conditions that may affect weight, eating behavior, (e.g; GI motility disorders, gastroparesis, chronic abdominal pain, eating disorders, or active psychological conditions).
  5. Pregnancy, breastfeeding, or any other condition that, in the opinion of the investigator or treating physician, would make participation unsafe or interfere with study procedures.
  6. Other cases deemed by the examining physician as unsuitable for safe treatment.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    ESG with Fundal Mucosal Ablation

    Device: Endoscopic Sleeve Gastroplasty (ESG) · Procedure: Fundal Mucosal Ablation

  • Active comparator
    Endoscopic Sleeve Gastroplasty (ESG) Alone

    Device: Endoscopic Sleeve Gastroplasty (ESG)

Interventions

  • DeviceEndoscopic Sleeve Gastroplasty (ESG)

    Endoscopic sleeve gastroplasty (ESG) is performed under general anesthesia using a flexible endoscope and full-thickness endoscopic suturing. Sutures are placed along the greater curvature of the stomach to create a smaller, sleeve-like gastric configuration while preserving the gastric fundus. The procedure is intended to reduce gastric volume, promote earlier satiety, and support weight loss.

  • ProcedureFundal Mucosal Ablation

    Fundal mucosal ablation is performed during the same procedural session as endoscopic sleeve gastroplasty. The gastric fundal mucosa is lifted using a submucosal injection of saline and methylene blue and then treated with controlled Hybrid Argon Plasma Coagulation. The procedure is intended to ablate superficial ghrelin-producing mucosa in the gastric fundus, potentially reducing hunger and supporting weight loss.

06

What researchers measure

Primary outcomes

  1. Percentage Change in Total Body Weight (%TBWL) from baseline to 1 month

    Time frame: Baseline to 1 month

  2. Percentage Change in Total Body Weight (%TBWL) from baseline to 3 month

    Time frame: Baseline to 3 month

  3. Percentage Change in Total Body Weight (%TBWL) from baseline to 6 month

    Time frame: Baseline to 6 month

  4. Percentage Change in Total Body Weight (%TBWL) from baseline to 9 month

    Time frame: Baseline to 9 month

  5. Percentage Change in Total Body Weight (%TBWL) from baseline to 12 month

    Time frame: Baseline to 12 month

Secondary outcomes

  1. Percent change in Excess Weight Loss (%EWL) from baseline to 1 month

    Time frame: Baseline to 1 month

  2. Percent change in Excess Weight Loss (%EWL) from baseline to 3 month

    Time frame: Baseline to 3 month

  3. Percent change in Excess Weight Loss (%EWL) from baseline to 6 month

    Time frame: Baseline to 6 month

  4. Percent change in Excess Weight Loss (%EWL) from baseline to 9 month

    Time frame: Baseline to 9 month

  5. Percent change in Excess Weight Loss (%EWL) from baseline to 12 month

    Time frame: Baseline to 12 month

  6. Number of Participants With Procedure-Related Adverse Events (1 Month)

    Time frame: Up to 1 month after procedure

  7. Number of Participants With Procedure-Related Adverse Events (3 Month)

    Time frame: Up to 3 month after procedure

  8. Number of Participants With Procedure-Related Adverse Events (6 Month)

    Time frame: Up to 6 month after procedure

  9. Number of Participants With Procedure-Related Adverse Events (9 Month)

    Time frame: Up to 9 month after procedure

  10. Number of Participants With Procedure-Related Adverse Events (12 Month)

    Time frame: Up to 12 month after procedure

  11. Change in Plasma Ghrelin level from baseline to 1 month

    Time frame: Baseline to 1 month

  12. Change in Plasma Ghrelin level from baseline to 6 month

    Time frame: Baseline to 6 month

  13. Change in Plasma Ghrelin level from baseline to 12 month

    Time frame: Baseline to 12 month

  14. Change in Systolic Blood Pressure from Baseline to 1 Month

    Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 1 month

  15. Change in Diastolic Blood Pressure from Baseline to 1 Month

    Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 1 month

  16. Change in Systolic Blood Pressure from Baseline to 3 Months

    Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 3 months

  17. Change in Diastolic Blood Pressure from Baseline to 3 Months

    Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 3 months

  18. Change in Systolic Blood Pressure from Baseline to 6 Months

    Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 6 months

  19. Change in Diastolic Blood Pressure from Baseline to 6 Months

    Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 6 months

  20. Change in Systolic Blood Pressure from Baseline to 9 Months

    Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 9 months

  21. Change in Diastolic Blood Pressure from Baseline to 9 Months

    Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 9 months

  22. Change in Systolic Blood Pressure from Baseline to 12 Months

    Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 12 months

  23. Change in Diastolic Blood Pressure from Baseline to 12 Months

    Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized blood pressure measurement procedure.

    Time frame: Baseline to 12 months

  24. Change in Fasting Plasma Glucose from Baseline to 1 Month

    Fasting plasma glucose concentration will be measured in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 1 month

  25. Change in Fasting Plasma Glucose from Baseline to 6 Months

    Fasting plasma glucose concentration will be measured in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 6 months

  26. Change in Fasting Plasma Glucose from Baseline to 12 Months

    Fasting plasma glucose concentration will be measured in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 12 months

  27. Change in Fasting Serum Insulin Concentration from Baseline to 1 Month

    Fasting serum insulin concentration will be measured in milli-international units per milliliter (mIU/mL).

    Time frame: Baseline to 1 month

  28. Change in Fasting Serum Insulin Concentration from Baseline to 6 Months

    Fasting serum insulin concentration will be measured in milli-international units per milliliter (mIU/mL).

    Time frame: Baseline to 6 months

  29. Change in Fasting Serum Insulin Concentration from Baseline to 12 Months

    Fasting serum insulin concentration will be measured in milli-international units per milliliter (mIU/mL).

    Time frame: Baseline to 12 months

  30. Change in Hemoglobin A1c (HbA1c) from Baseline to 1 Month

    HbA1c will be measured as a percentage (%) of total hemoglobin.

    Time frame: Baseline to 1 month

  31. Change in Hemoglobin A1c (HbA1c) from Baseline to 6 Months

    HbA1c will be measured as a percentage (%) of total hemoglobin.

    Time frame: Baseline to 6 months

  32. Change in Hemoglobin A1c (HbA1c) from Baseline to 12 Months

    HbA1c will be measured as a percentage (%) of total hemoglobin.

    Time frame: Baseline to 12 months

  33. Change in Total Cholesterol from Baseline to 1 Month

    Total cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 1 month

  34. Change in Total Cholesterol from Baseline to 6 Months

    Total cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 6 months

  35. Change in Total Cholesterol from Baseline to 12 Months

    Total cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 12 months

  36. Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 1 Month

    Low-density lipoprotein (LDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 1 month

  37. Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 6 Months

    Low-density lipoprotein (LDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 6 months

  38. Change in Low-Density Lipoprotein (LDL) Cholesterol from Baseline to 12 Months

    Low-density lipoprotein (LDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 12 months

  39. Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 1 Month

    High-density lipoprotein (HDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 1 month

  40. Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 6 Months

    High-density lipoprotein (HDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 6 months

  41. Change in High-Density Lipoprotein (HDL) Cholesterol from Baseline to 12 Months

    High-density lipoprotein (HDL) cholesterol concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 12 months

  42. Change in Triglycerides from Baseline to 1 Month

    Serum triglyceride concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 1 month

  43. Change in Triglycerides from Baseline to 6 Months

    Serum triglyceride concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 6 months

  44. Change in Triglycerides from Baseline to 12 Months

    Serum triglyceride concentration will be measured from fasting blood samples and in milligrams per deciliter (mg/dL).

    Time frame: Baseline to 12 months

  45. Change in Hepatic Steatosis Index (HSI) from Baseline to 1 Month

    HSI is a calculated score used to estimate the likelihood of hepatic steatosis. Higher scores indicate a greater likelihood of hepatic steatosis.

    Time frame: Baseline to 1 month

  46. Change in Hepatic Steatosis Index (HSI) from Baseline to 6 Months

    HSI is a calculated score used to estimate the likelihood of hepatic steatosis. Higher scores indicate a greater likelihood of hepatic steatosis.

    Time frame: Baseline to 6 months

  47. Change in Hepatic Steatosis Index (HSI) from Baseline to 12 Months

    HSI is a calculated score used to estimate the likelihood of hepatic steatosis. Higher scores indicate a greater likelihood of hepatic steatosis.

    Time frame: Baseline to 12 months

  48. Change in Liver Stiffness Measurement from Baseline to 1 Month

    Liver fibrosis will be assessed by FibroScan. Liver stiffness will be measured in kilopascals (kPa), with higher liver stiffness values indicating greater liver fibrosis.

    Time frame: Baseline to 1 month

  49. Change in Liver Stiffness Measurement from Baseline to 6 Months

    Liver fibrosis will be assessed by FibroScan. Liver stiffness will be measured in kilopascals (kPa), with higher liver stiffness values indicating greater liver fibrosis.

    Time frame: Baseline to 6 months

  50. Change in Liver Stiffness Measurement from Baseline to 12 Months

    Liver fibrosis will be assessed by FibroScan. Liver stiffness will be measured in kilopascals (kPa), with higher liver stiffness values indicating greater liver fibrosis.

    Time frame: Baseline to 12 months

  51. Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 1 Month

    Upper GI symptoms will be assessed using the Upper Gastrointestinal Disorders Symptoms Questionnaire. Scores range from 0 to 5, with higher scores indicating severe GI symptoms.

    Time frame: Baseline to 1 month

  52. Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 3 Months

    Upper GI symptoms will be assessed using the Upper Gastrointestinal Disorders Symptoms Questionnaire. Scores range from 0 to 5, with higher scores indicating severe GI symptoms.

    Time frame: Baseline to 3 months

  53. Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 6 Months

    Upper GI symptoms will be assessed using the Upper Gastrointestinal Disorders Symptoms Questionnaire. Scores range from 0 to 5, with higher scores indicating severe GI symptoms.

    Time frame: Baseline to 6 months

  54. Change in Upper Gastrointestinal Disorders Symptoms from Baseline to 12 Months

    Upper GI symptoms will be assessed using the Upper Gastrointestinal Disorders Symptoms Questionnaire. Scores range from 0 to 5, with higher scores indicating severe GI symptoms.

    Time frame: Baseline to 12 months

  55. Change in plasma leptin level from baseline to 1 month

    Time frame: Baseline to 1 month

  56. Change in plasma leptin level from baseline to 6 months

    Time frame: Baseline to 6 months

  57. Change in plasma leptin level from baseline to 12 months

    Time frame: Baseline to 12 months

  58. Change in resistance to overeating from baseline to 1 month

    Change in resistance to overeating will be assessed using the Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF). Scores range from 0 to 3, with higher scores indicating successful resistance to the desire to overeat.

    Time frame: Baseline to 1 month

  59. Change in resistance to overeating from baseline to 3 months

    Change in resistance to overeating will be assessed using the Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF). Scores range from 0 to 3, with higher scores indicating successful resistance to the desire to overeat.

    Time frame: Baseline to 3 months

  60. Change in resistance to overeating from baseline to 6 months

    Change in resistance to overeating will be assessed using the Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF). Scores range from 0 to 3, with higher scores indicating successful resistance to the desire to overeat.

    Time frame: Baseline to 6 months

  61. Change in resistance to overeating from baseline to 12 months

    Change in resistance to overeating will be assessed using the Weight Efficacy Lifestyle Questionnaire Short-Form (WEL-SF). Scores range from 0 to 3, with higher scores indicating successful resistance to the desire to overeat.

    Time frame: Baseline to 12 months

  62. Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 1 month

    Change in hunger, appetite, food cravings, and post-meal satiety will be assessed using the Daily Eats Measuring Daily Eating Factors (DAILY EATS). Scores range from 0 to 10, with higher scores indicating increased hunger.

    Time frame: Baseline to 1 month

  63. Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 3 months

    Change in hunger, appetite, food cravings, and post-meal satiety will be assessed using the Daily Eats Measuring Daily Eating Factors (DAILY EATS). Scores range from 0 to 10, with higher scores indicating increased hunger.

    Time frame: Baseline to 3 months

  64. Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 6 months

    Change in hunger, appetite, food cravings, and post-meal satiety will be assessed using the Daily Eats Measuring Daily Eating Factors (DAILY EATS). Scores range from 0 to 10, with higher scores indicating increased hunger.

    Time frame: Baseline to 6 months

  65. Change in hunger, appetite, food cravings, and post-meal satiety from baseline to 12 months

    Change in hunger, appetite, food cravings, and post-meal satiety will be assessed using the Daily Eats Measuring Daily Eating Factors (DAILY EATS). Scores range from 0 to 10, with higher scores indicating increased hunger.

    Time frame: Baseline to 12 months

07

Study locations

1 of 1 sites recruiting
  • West Virginia University
    Morgantown, West Virginia 26506, United States
    Recruiting
    • Zim Warda Hasan, MBBS, MS · Contactzh00027@mix.wvu.edu · 364-203-1900
    • Shailendra Singh, MD, FASGE · Principal investigator
    • Zim Warda Hasan, MBBS, MS · Sub investigator
08

References and documents

Publications

  • Gadde KM, Atkins KD. The limits and challenges of antiobesity pharmacotherapy. Expert Opin Pharmacother. 2020 Aug;21(11):1319-1328. doi: 10.1080/14656566.2020.1748599. Epub 2020 Apr 15. PubMed 32292094 ↗
  • Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24. PubMed 23711556 ↗
  • Gadi SRV, Maselli DB, Donnangelo LL, Wooley C, Comer T, Casey S, Jain A, Jain A, Chapman CG, Bakheet N, Badurdeen D, Kumbhari V, McGowan CE. Gastric fundal mucosal ablation followed by endoscopic sleeve gastroplasty in adults with obesity: a first-in-human two-phase pilot clinical trial. Endoscopy. 2026 Mar 26. doi: 10.1055/a-2823-8603. Online ahead of print. PubMed 41760139 ↗
  • Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28. PubMed 35908555 ↗
  • Maselli DB, Donnangelo LL, Wooley C, Chapman C, Kumbhari V, Mcgowan CE. Endoscopic Gastric Fundal Mucosal Ablation Induces Weight Loss in Adults With Obesity. Gastroenterology. 2024 Dec;167(7):1457-1459.e3. doi: 10.1053/j.gastro.2024.08.008. Epub 2024 Aug 21. No abstract available. PubMed 39154777 ↗
  • Chao AM, Paul A, Hodgkins JV, Wadden TA. A Guideline-Directed Approach to Obesity Treatment. Diabetes Spectr. 2024 Nov 15;37(4):281-295. doi: 10.2337/dsi24-0001. eCollection 2024 Fall. PubMed 39649692 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 15, 2026
Sites
West Virginia University is now Recruiting
Oct 15, 2026
Start date
Sep 2026→Oct 2026
Oct 15, 2026
Interventions
Added Device: Endoscopic Sleeve Gastroplasty (ESG); removed Procedure: Endoscopic Sleeve Gastroplasty (ESG)
Oct 15, 2026
Secondary outcomes
7 edited, 11 added
What changed in the outcomes
  • EditedChange in SerumPlasma Ghrelin level from baseline to 1 monthTime frame: Baseline to 1 month
  • EditedChange in SerumPlasma Ghrelin level from baseline to 6 monthTime frame: Baseline to 6 month
  • EditedChange in SerumPlasma Ghrelin level from baseline to 12 monthTime frame: Baseline to 12 month
  • EditedChange in Quality of Life ScoreUpper Gastrointestinal Disorders Symptoms from Baseline to 1 MonthTime frame: Baseline to 1 month
  • EditedChange in Quality of Life ScoreUpper Gastrointestinal Disorders Symptoms from Baseline to 3 MonthsTime frame: Baseline to 3 months
  • EditedChange in Quality of Life ScoreUpper Gastrointestinal Disorders Symptoms from Baseline to 6 MonthsTime frame: Baseline to 6 months
  • EditedChange in Quality of Life ScoreUpper Gastrointestinal Disorders Symptoms from Baseline to 12 MonthsTime frame: Baseline to 12 months
  • AddedChange in plasma leptin level from baseline to 1 monthTime frame: Baseline to 1 month
  • AddedChange in plasma leptin level from baseline to 6 monthsTime frame: Baseline to 6 months
  • AddedChange in plasma leptin level from baseline to 12 monthsTime frame: Baseline to 12 months
  • AddedChange in resistance to overeating from baseline to 1 monthTime frame: Baseline to 1 month
  • AddedChange in resistance to overeating from baseline to 3 monthsTime frame: Baseline to 3 months
  • AddedChange in resistance to overeating from baseline to 6 monthsTime frame: Baseline to 6 months
  • AddedChange in resistance to overeating from baseline to 12 monthsTime frame: Baseline to 12 months
  • AddedChange in hunger, appetite, food cravings, and post-meal satiety from baseline to 1 monthTime frame: Baseline to 1 month
  • AddedChange in hunger, appetite, food cravings, and post-meal satiety from baseline to 3 monthsTime frame: Baseline to 3 months
  • AddedChange in hunger, appetite, food cravings, and post-meal satiety from baseline to 6 monthsTime frame: Baseline to 6 months
  • AddedChange in hunger, appetite, food cravings, and post-meal satiety from baseline to 12 monthsTime frame: Baseline to 12 months
Oct 15, 2026
Contact
Study contact changed: z•••@mix.wvu.edu · •••1900→z•••@mix.wvu.edu · •••1900. See the current contact
Oct 15, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • West Virginia University · Morgantown, United StatesContact z•••@mix.wvu.edu · •••1900→z•••@mix.wvu.edu · •••1900Contact added (no phone or email listed)
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Not yet recruiting→Recruiting
    West Virginia University is now Recruiting
    Start date Sep 2026→Oct 2026
    Secondary outcomes 7 edited, 11 added
    What changed in the outcomes
    • EditedChange in SerumPlasma Ghrelin level from baseline to 1 monthTime frame: Baseline to 1 month
    • EditedChange in SerumPlasma Ghrelin level from baseline to 6 monthTime frame: Baseline to 6 month
    • EditedChange in SerumPlasma Ghrelin level from baseline to 12 monthTime frame: Baseline to 12 month
    • EditedChange in Quality of Life ScoreUpper Gastrointestinal Disorders Symptoms from Baseline to 1 MonthTime frame: Baseline to 1 month
    • EditedChange in Quality of Life ScoreUpper Gastrointestinal Disorders Symptoms from Baseline to 3 MonthsTime frame: Baseline to 3 months
    • EditedChange in Quality of Life ScoreUpper Gastrointestinal Disorders Symptoms from Baseline to 6 MonthsTime frame: Baseline to 6 months
    • EditedChange in Quality of Life ScoreUpper Gastrointestinal Disorders Symptoms from Baseline to 12 MonthsTime frame: Baseline to 12 months
    • AddedChange in plasma leptin level from baseline to 1 monthTime frame: Baseline to 1 month
    • AddedChange in plasma leptin level from baseline to 6 monthsTime frame: Baseline to 6 months
    • AddedChange in plasma leptin level from baseline to 12 monthsTime frame: Baseline to 12 months
    • AddedChange in resistance to overeating from baseline to 1 monthTime frame: Baseline to 1 month
    • AddedChange in resistance to overeating from baseline to 3 monthsTime frame: Baseline to 3 months
    • AddedChange in resistance to overeating from baseline to 6 monthsTime frame: Baseline to 6 months
    • AddedChange in resistance to overeating from baseline to 12 monthsTime frame: Baseline to 12 months
    • AddedChange in hunger, appetite, food cravings, and post-meal satiety from baseline to 1 monthTime frame: Baseline to 1 month
    • AddedChange in hunger, appetite, food cravings, and post-meal satiety from baseline to 3 monthsTime frame: Baseline to 3 months
    • AddedChange in hunger, appetite, food cravings, and post-meal satiety from baseline to 6 monthsTime frame: Baseline to 6 months
    • AddedChange in hunger, appetite, food cravings, and post-meal satiety from baseline to 12 monthsTime frame: Baseline to 12 months
    Interventions Added Device: Endoscopic Sleeve Gastroplasty (ESG); removed Procedure: Endoscopic Sleeve Gastroplasty (ESG)
    Contact Study contact changed: z•••@mix.wvu.edu · •••1900→z•••@mix.wvu.edu · •••1900. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • West Virginia University · Morgantown, United StatesContact z•••@mix.wvu.edu · •••1900→z•••@mix.wvu.edu · •••1900Contact added (no phone or email listed)
    + 2 other changes: verification date and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07792226
Lead sponsor
West Virginia University
Responsible party
Shailendra Singh (Professor & Director of Advanced Therapeutic Endoscopy, Director of Bariatric Endoscopy, West Virginia University) — Principal investigator
First posted
Aug 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Oct 19, 2026

Study contacts

Zim Warda Hasan, MBBS, MS
Contact
zh00027@mix.wvu.edu
364-203-1900
Shailendra Singh, MD, FASGE
principal investigator · West Virginia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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