Status:
NOT_YET_RECRUITING
Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Obesity and Obesity-related Medical Conditions
Weight Loss
Eligibility:
All Genders
18+ years
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
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
January 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06894498
Start Date
January 1 2026
End Date
October 1 2026
Last Update
December 18 2025
Active Locations (5)
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1
Endeavor Health Evanston Hospital
Evanston, Illinois, United States, 60201
2
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States, 77401
3
CHU de Strasbourg, IHU-Strasbourg
Strasbourg, France, 67000
4
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy, 00168