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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Weight Loss; Gastro Esophageal Reflux; Bariatric Surgery Candidate; Obesity

Treatments: Other: Endoscopic Bariatric Therapies

Study type: Observational

Funder types: Other

Identifiers

NCT04494048

1510016654

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,999 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

9,999 participants in 1 patient group

Endoscopic Bariatric Therapies (EBT).

Description:

patients undergoing Endoscopic Bariatric Therapies

Treatment:

Other: Endoscopic Bariatric Therapies