Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss

Not yet recruiting

• Conditions: Obesity and Obesity-related Medical Conditions; Weight Loss

• Registration Number: NCT06894498
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.

Detailed Description

Includes retrospective data collection and one prospective visit

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-24
• Study Start: 2025-08-01
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Subject is ≥ 18 years of age at the time of the ESG procedure
• Subject with a BMI between 30 kg/m2 and 50 kg/m2, inclusive, at the time of the primary ESG procedure using Overstitch Endoscopic Suturing System
• Subject completed follow-up 1-year from the ESG procedure for weight loss management
• Subject completed or is eligible for follow-up 5-years from the ESG procedure for weight loss management (visit can be collected either retrospectively or prospectively)
• Subject has returned for a minimum of one annual follow-up at the treating site for weight loss management annually between two and four years from the procedure.
• Subject is willing to complete one prospective visit (5 year or 5+ year, as appropriate)
• Subject is able to read, understand, and sign a written Informed Consent Form to participate in the study

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects that maintain clinically significant weightloss at five-year visit	TBWL assessed at five-years post ESG	Proportion of subjects that maintain clinically significant weight loss (responders). Maintenance of clinically significant weight loss is defined as ≥ 7.5% TBWL (Total Body Weight Loss) at the five-year visit in those subjects that attained ≥10% TBWL at 1 year from the original ESG procedure. Subjects that had adjunctive bariatric surgery following ESG will be considered non-responders despite the weight loss percentage reported for all study visits following the bariatric surgery.

Trial Locations

Locations (3)

Endeavor Health Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Bellaire, Texas, United States

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy