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

Weill Medical College of Cornell University9,999 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

9,999

Conditions

Obesity Weight Loss Gastro Esophageal Reflux Bariatric Surgery Candidate

Outcomes

Primary Outcomes

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

Secondary Outcomes

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