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Enrolling by invitationNCT05725967EMBTsUpdated Dec 2, 2025

Endoscopic Metabolic and Bariatric Therapies

An observational study in Obesity, Obesity, Morbid and Obesity Associated Disorder, sponsored by Christopher C. Thompson, MD, MSc. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Christopher C. Thompson, MD, MSc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years to 80 Years
Sex
All
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Study summary

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

Read the detailed description

The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

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Conditions studied

  • Obesity
  • Obesity, Morbid
  • Obesity Associated Disorder
  • Bariatric Surgery Candidate
  • Fistula, Gastric
  • Roux-en-y Anastomosis Site
  • Ulcer, Gastric
  • Abdominal Pain
  • Abdominal Obesity
  • Complication of Surgical Procedure
  • Complication of Treatment
  • Complication,Postoperative
  • Weight Gain
  • Weight Loss
  • Leak, Anastomotic
  • Delayed Gastric Emptying Following Procedure

Keywords

  • Roux-en-Y Gastric Bypass
  • Sleeve Gastrectomy
  • laparoscopic adjustable gastric banding
  • gastroplasty with endoscopic myotomy (GEM)
  • endoscopic sleeve gastroplasty (ESG)
  • transoral outlet reduction (TORe)
  • primary obesity surgery endoluminal (POSE)
  • restorative obesity surgery endoluminal (ROSE)
  • intragastric balloons (IGB)
  • aspiration therapy
  • pylorus sparing antral myotomy (PSAM)
  • gastric emptying breath test (GEBT)
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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 5,000 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Christopher C. Thompson, MD, MSc is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients registered with Mass General Brigham affiliate facilities who have undergone an endoscopic primary obesity procedure, an endoscopic bariatric revision procedure, or a bariatric surgical procedure.

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

  • patients from Mass General Brigham
  • any patient having an endoscopic primary obesity procedure
  • any patient having an endoscopic post-bariatric surgical revision procedure
  • any patient having a bariatric surgical procedure

Exclusion criteria

Exclusion Criteria:

  • patients without past surgical and medical history medical records in the Mass General Brigham system
  • patients unwilling to allow for medical record review at Mass General Brigham
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Primary Obesity Endoscopic Procedures

    Primary endoscopic procedures for treatment of obesity.

    Procedure: Primary Obesity Endoscopic Procedures · Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction · Device: Intragastric Balloon · Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal · Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy · Device: Aspiration Therapy

  • Endoscopic Revision of Bariatric Surgical Procedures

    Endoscopic revision of post-bariatric surgical complications.

    Procedure: Endoscopic Revision of Bariatric Surgical Procedures · Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction · Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal · Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy

  • Bariatric Surgery Procedures

    Bariatric surgical procedures.

    Procedure: Bariatric Surgery Procedures

Interventions

  • ProcedurePrimary Obesity Endoscopic Procedures

    Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).

    Also known as: ESG, Aspiration Therapy, IGB, POSE, GEM, PSAM, BEAM, EMBTs

  • ProcedureEndoscopic Revision of Bariatric Surgical Procedures

    Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.

    Also known as: TORe, ROSE, APC

  • ProcedureBariatric Surgery Procedures

    Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)

    Also known as: RYGB, LSG, LAGB

  • DeviceEndoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction

    Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.

    Also known as: ESG, TORe

  • DeviceIntragastric Balloon

    An endoscopic bariatric procedure involving the placement of an intragastric balloon.

    Also known as: IGB

  • DevicePrimary obesity surgery endoluminal, Restorative obesity surgery endoluminal

    Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.

    Also known as: POSE, ROSE

  • DeviceArgon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy

    Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.

    Also known as: APC, GEM, BEAM, PSAM

  • DeviceAspiration Therapy

    Placement of an aspiration therapy device for the treatment of obesity.

    Also known as: Aspire

06

What researchers measure

Primary outcomes

  1. Change in weight from pre-procedure to 10 years

    %TBWL

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  2. Change in hypertension from pre-procedure to 10 years using blood pressure measurements

    Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  3. Change in hypertension from pre-procedure to 10 years using medication dosages

    Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  4. Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years

    Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  5. Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years

    Change of HgA1c (%) by comparing lab values from baseline through 10 years.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  6. Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years

    Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  7. Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years

    Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  8. Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years

    Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  9. Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years

    Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  10. Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years

    Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  11. Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years

    Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

  12. Change in rate of adverse events from procedure to 10 years

    Change in rate of adverse events post-procedure through 10 years

    Time frame: Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  13. Change in comorbidity medication dosages from baseline to 10 years

    Change of dosage of comorbidity medications compared to baseline

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

Secondary outcomes

  1. Change in gastric motility from baseline to 10 years

    Gastric emptying breath test

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  2. Change in PYY gut hormones from baseline to 10 years

    PYY lab values will be compared to baseline

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  3. Change in GLP1 gut hormones from baseline to 10 years

    GLP1 lab values will be compared to baseline

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  4. Change in ghrelin hormones from baseline to 10 years

    Ghrelin lab values will be compared to baseline

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

  5. Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years

    Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures

    Time frame: Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery

07

Study locations

1 site
08

References and documents

Publications

  • 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 ↗
  • Jirapinyo P, Thompson CC. Endoscopic gastric plication for the treatment of weight regain after Roux-en-Y gastric bypass (with video). Gastrointest Endosc. 2022 Jul;96(1):51-56. doi: 10.1016/j.gie.2022.02.051. Epub 2022 Mar 5. PubMed 35259393 ↗
  • de Moura DTH, Hirsch BS, Boghossian MB, de Medeiros FS, McCarty TR, Thompson CC, de Moura EGH. Low-cost modified endoscopic vacuum therapy using a triple-lumen tube allows nutrition and drainage for treatment of an early post-bariatric surgery leak. Endoscopy. 2022 Jul;54(7):E376-E377. doi: 10.1055/a-1540-5870. Epub 2021 Aug 9. No abstract available. PubMed 34374043 ↗
  • de Moura DTH, de Freitas Junior JR, de Souza GMV, de Oliveira GHP, McCarty TR, Thompson CC, de Moura EGH. Endoscopic management of acute leak after sleeve gastrectomy: principles and techniques. Endoscopy. 2022 Jul;54(7):E327-E328. doi: 10.1055/a-1525-1661. Epub 2021 Jul 9. No abstract available. PubMed 34243196 ↗
  • Sanchez-Luna SA, Thompson CC, De Moura EGH, de Medeiros FS, De Moura DTH. Modified endoscopic vacuum therapy: Are we ready for prime time? Gastrointest Endosc. 2022 Jun;95(6):1281-1282. doi: 10.1016/j.gie.2021.12.049. No abstract available. PubMed 35589208 ↗
  • Bazarbashi AN, Dolan RD, McCarty TR, Jirapinyo P, Thompson CC. Endoscopic revision of gastrojejunal anastomosis for the treatment of dumping syndrome in patients with Roux-en-Y gastric bypass: a systematic review and meta-analysis. Surg Endosc. 2022 Jun;36(6):4099-4107. doi: 10.1007/s00464-021-08731-4. Epub 2021 Oct 20. PubMed 34669046 ↗
  • Jirapinyo P, Thompson CC. Primary Bariatric Procedures. Dig Dis Sci. 2022 May;67(5):1674-1687. doi: 10.1007/s10620-022-07393-z. Epub 2022 Mar 29. PubMed 35348970 ↗
  • Argueta PP, Salazar M, Vargo JJ, Chahal P, Rodriguez JJ, Simons-Linares CR, Thompson CC. Thirty-Day Readmission After Bariatric Surgery: Causes, Effects on Outcomes, and Predictors. Dig Dis Sci. 2022 Mar;67(3):834-843. doi: 10.1007/s10620-021-06934-2. Epub 2021 Jun 24. PubMed 34169433 ↗
  • Jirapinyo P, McCarty TR, Dolan RD, Shah R, Thompson CC. Effect of Endoscopic Bariatric and Metabolic Therapies on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2022 Mar;20(3):511-524.e1. doi: 10.1016/j.cgh.2021.03.017. Epub 2021 Mar 13. PubMed 33727164 ↗
  • Singh S, Bazarbashi AN, Khan A, Chowdhry M, Bilal M, de Moura DTH, Jirapinyo P, Thakkar S, Thompson CC. Primary obesity surgery endoluminal (POSE) for the treatment of obesity: a systematic review and meta-analysis. Surg Endosc. 2022 Jan;36(1):252-266. doi: 10.1007/s00464-020-08267-z. Epub 2021 Feb 1. PubMed 33523277 ↗
  • Thompson CC, Jirapinyo P, Shah R, Simsek C. Gastroplasty With Endoscopic Myotomy (GEM) for the Treatment of Obesity: Preliminary Efficacy and Physiologic Results. Gastroenterology. 2022 Nov;163(5):1173-1175. doi: 10.1053/j.gastro.2022.07.077. Epub 2022 Aug 10. No abstract available. PubMed 35961376 ↗
  • Jirapinyo P, Thompson CC. Comparison of distal primary obesity surgery endolumenal techniques for the treatment of obesity (with videos). Gastrointest Endosc. 2022 Sep;96(3):479-486. doi: 10.1016/j.gie.2022.04.1346. Epub 2022 May 11. PubMed 35568242 ↗

Individual participant data

Plan to share: Undecided — Depending on the range of data and publication status, the PI will consider de-identified data sharing with a data transfer agreement in place after discussion of parameters and study design.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05725967
Lead sponsor
Christopher C. Thompson, MD, MSc
Responsible party
Christopher C. Thompson, MD, MSc (Director of Endoscopy, Brigham and Women's Hospital) — Sponsor-investigator
First posted
Feb 13, 2023
Start date
Jul 8, 2022
Primary completion
May 28, 2028 (estimated)
Completion
May 28, 2029 (estimated)
Last update
Dec 2, 2025

Study contacts

Christopher C. Thompson, MD, MSc
principal investigator · Brigham and Women's Hospital

Oversight

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

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