NCT05514288

Benefits of Endoscopic Bariatric Procedures

Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty \[ESG\] or transoral outlet reduction \[TORe\]) as clinically indicated, and subsequent follow up clinic visits for up to one year.

Detailed description

The purpose the research is to better understand the effects of endoscopic bariatric therapy (EBT) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures. The primary research procedures are: * EBT procedure (endoscopic sleeve gastroplasty \[ESG\] or transoral outlet reduction \[TORe\]) * Behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification * Collection of blood to evaluate changes in hormonal profiles

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	Endobariatric procedure	Endoscopic sleeve gastroplasty or transoral outlet reduction

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-08-24
• Last updated: 2024-08-26

Locations

1 site across 1 country: United States