NCT06894498Recruiting
Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
Boston Scientific Corporation
Start Date
3/31/2026
Completion Date
12/1/2026
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
Age Range: 18 years to No maximum
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
Interventions
OTHER
No Intervention: Observational Cohort
Conditions
Obesity and Obesity-related Medical ConditionsWeight Loss
Locations
Endeavor Health Evanston Hospital
Evanston, Illinois 60201
United States
The University of Texas Health Science Center at Houston
Bellaire, Texas 77401
United States
The BMI Clinic
Double Bay, New South Wales 2028
Australia
CHU de Strasbourg, IHU-Strasbourg
Strasbourg, 67000
France
Mohak hi-tech Specialty Hospital
Indore, Madhya Pradesh 453555
India
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Italy
New You Medical Center
Riyadh, 11671
Saudi Arabia
Spire Southampton
Southampton, Hampshire SO16 6UY
United Kingdom