Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic Bariatric Therapies.
- Who it may be relevant to
- Registry conditions: Obesity, Weight Loss, Gastro Esophageal Reflux, Bariatric Surgery Candidate. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Other Endoscopic 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
Primary outcome measures
- Change of weight of the various bariatric therapies [Time frame: Baseline, 1 month, 6 months, and 1 year post procedure]
- Safety of procedure measured by in the number of adverse events of procedure [Time frame: at baseline]
- Safety of procedure measured by in the number of adverse events that occur within 30 days [Time frame: Within 30 days of the procedure]
Secondary outcome measures (9)
- Technical success of each bariatric therapy. [Time frame: through study completion at one year.]
- Change and Improvement in comorbidities [Time frame: 6 months, 1 year post procedure]
- Change and Improvement in comorbidities [Time frame: 6 months, 1 year post procedure]
- Change and Improvement in comorbidities [Time frame: 6 months, 1 year post procedure]
- Change in the effect of Endoscopic Bariatric Therapies on reflux [Time frame: Baseline, 6 months,and 1 year post procedure]
- Change in the effect of Endoscopic Bariatric Therapies on reflux [Time frame: Baseline, 6 months,and 1 year post procedure]
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Time frame: Baseline, 6 months,and 1 year post procedure]
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Time frame: Baseline, 6 months,and 1 year post procedure]
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Time frame: Baseline, 6 months,and 1 year post procedure]
Eligibility criteria
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
- Any patient who has not undergone or will undergo EBT for weight loss
- Below 18 years of age.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
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. PMID 39694295
Identifiers
NCT: NCT04494048 · 1510016654