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RecruitingNCT04494048EBTUpdated Apr 23, 2026

Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

An observational study in Obesity, Weight Loss and Gastro Esophageal Reflux, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Weill Medical College of Cornell University · Observational

From the registry’s dates

  • Started Apr 2016; still recruiting 10 years 6 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
9,999
Ages
18 Years to 89 Years
Sex
All
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Study summary

The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 1 years after a subject consents for study participation.

Read the detailed description

Endoscopic bariatric therapies such as intragastric balloons, space occupying EBTs, endoscopic sleeve gastroplasty (ESG), primary obesity surgery endolumenal (POSE), and small bowel interventions including gastrointestinal bypass sleeves, etc. are recommended alone or in conjunction with other weight loss treatment modules for patients who cannot or do not want to undergo conventional bariatric surgery or other therapies for obesity (with BMI ≥30 kg/m2) or BMI >27 with comorbidities.

This research is being done in order to find out if endoscopic bariatric therapies work as well as, or better or worse than, other currently available treatment modules to achieve weight loss.

The study is to create a registry to analyze a longitudinal observational cohort of patients who have undergone endobariatric procedures. We will collect information through standard of practice visits and through chart review.

Laboratory data, patient characteristics, imaging, histology will be collected. In certain patients - after specific consent extra blood may be collected for research purposes.

02

Conditions studied

  • Obesity
  • Weight Loss
  • Gastro Esophageal Reflux
  • Bariatric Surgery Candidate
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 9,999 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Individuals who will undergo Endoscopic bariatric therapies.

Inclusion criteria

  • Any patient who is considering undergoing EBT for weight loss within 6 months, or has undergone clinically indicated EBT for weight loss within the past 6 months
  • Above or equal to 18 years of age.

Exclusion criteria

Exclusion Criteria:

  • Any patient who has not undergone or will undergo EBT for weight loss
  • Below 18 years of age.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
9,999 participants (estimated)
Patient registry
No

Groups and cohorts

  • Endoscopic Bariatric Therapies (EBT).

    patients undergoing Endoscopic Bariatric Therapies

    Other: Endoscopic Bariatric Therapies

Interventions

  • OtherEndoscopic Bariatric Therapies

    Participation in this study will allow for data collection through medical chart review for at least 6 standard of care visits up to 1 year after consenting to participate in this registry study. The exposure of interest is total body weight loss, safety and efficacy

06

What researchers measure

Primary outcomes

  1. Change of weight of the various bariatric therapies

    Compare mean percentage total body weight loss achieved via various Endoscopic Bariatric Therapies compared to baseline, 1 month, 6 months and 1 . year post procedure. This will be calculated by measuring the patients weight on a scale and comparing it to their baseline weight pre procedure.

    Time frame: Baseline, 1 month, 6 months, and 1 year post procedure

  2. Safety of procedure measured by in the number of adverse events of procedure

    Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline

    Time frame: at baseline

  3. Safety of procedure measured by in the number of adverse events that occur within 30 days

    Number of adverse events; Type (unexpected, expected, related, possibly related)

    Time frame: Within 30 days of the procedure

Secondary outcomes

  1. Technical success of each bariatric therapy.

    Technical success is the technical success of the procedure.

    Time frame: through study completion at one year.

  2. Change and Improvement in comorbidities

    measuring certain anthropometric measurements at baseline and at 6 months and one year. Waist Circumference in cm

    Time frame: 6 months, 1 year post procedure

  3. Change and Improvement in comorbidities

    measuring certain anthropometric measurements at baseline and at 6 months and one year. Blood pressure mmHg

    Time frame: 6 months, 1 year post procedure

  4. Change and Improvement in comorbidities

    measuring certain anthropometric measurements at baseline and at 6 months and one year. These include laboratory measurements (tryglicerides, LDL, A1C, Insulin)

    Time frame: 6 months, 1 year post procedure

  5. Change in the effect of Endoscopic Bariatric Therapies on reflux

    measuring change in gastrointestinal reflux disease (GERD) questionnaire answers

    Time frame: Baseline, 6 months,and 1 year post procedure

  6. Change in the effect of Endoscopic Bariatric Therapies on reflux

    measuring change in ph measurement on ph manometry

    Time frame: Baseline, 6 months,and 1 year post procedure

  7. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Measuring change in fibroscan score

    Time frame: Baseline, 6 months,and 1 year post procedure

  8. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Measuring change in liver biopsy results

    Time frame: Baseline, 6 months,and 1 year post procedure

  9. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Measuring change in liver functions tests (on blood draw alanine alanine aminotransferase (ALT), AST (aspartate aminotransferase) )

    Time frame: Baseline, 6 months,and 1 year post procedure

07

Study locations

1 of 1 sites recruiting
  • Weill Cornell Medicine
    New York, New York 10021, United States
    Recruiting
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References and documents

Publications

  • Lahooti A, Westerveld D, Johnson K, Aneke-Nash C, Baig MU, Akagbosu C, Hanscom M, Buckholz A, Newberry C, Herr A, Schwartz R, Yeung M, Sampath K, Mahadev S, Kumar S, Carr-Locke D, Aronne L, Shukla A, Sharaiha RZ. Improvement in obesity-related comorbidities 5 years after endoscopic sleeve gastroplasty: a prospective cohort study. Gastrointest Endosc. 2025 Jul;102(1):26-36. doi: 10.1016/j.gie.2024.12.017. Epub 2024 Dec 16. PubMed 39694295 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04494048
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Jul 31, 2020
Start date
Apr 5, 2016
Primary completion
Oct 31, 2035 (estimated)
Completion
Oct 31, 2035 (estimated)
Last update
Apr 23, 2026

Study contacts

Reem Z Sharaiha, MD, MSc.
Contact
rzs9001@med.cornell.edu
646-962-2382
Andrea M Herr, NP
Contact
anb9057@med.cornell.edu
646-962-2382
Reem Z Sharaiha, MD
principal investigator · Weill Medical College of Cornell University

Oversight

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

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