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
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.
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.
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 →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.
Individuals who will undergo Endoscopic bariatric therapies.
Exclusion Criteria:
patients undergoing Endoscopic Bariatric Therapies
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
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
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
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
Technical success of each bariatric therapy.
Technical success is the technical success of the procedure.
Time frame: through study completion at one year.
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
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
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
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
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
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
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
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
Plan to share: No
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Weill Medical College of Cornell University