NCT04494048

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 9,999 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: —

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-04-05
• Primary completion: 2035-10-31
• Completion: 2035-10-31
• First posted: 2020-07-31
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States