Five-plus year outcomes after endoscopic sleeve gastroplasty for lasting weight loss
Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
This study will see if people who had endoscopic sleeve gastroplasty keep their weight off five or more years afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Scientific Corporation Industry-sponsored |
| Locations | 8 sites (Evanston, Illinois and 7 other locations) |
| Trial ID | NCT06894498 on ClinicalTrials.gov |
What this trial studies
This observational cohort collects retrospective clinical data and includes one prospective 5-year visit to document long-term weight outcomes after ESG performed with the OverStitch endoscopic suturing system. Eligible adults had a primary ESG at least five years before enrollment, had a BMI of 30–50 kg/m2 at the time of that procedure, and completed early follow-up visits including a 1-year visit and annual follow-ups between years 2–4. Study sites are in Illinois, Texas, and New South Wales and the sponsor is Boston Scientific Corporation. No experimental treatments are given; investigators will analyze weight-change trajectories and related clinical data to characterize the durability of weight loss after ESG.
Who should consider this trial
Good fit: Ideal candidates are adults who received a primary OverStitch ESG at least five years ago, had a BMI of 30–50 at the time of the procedure, completed required early follow-ups, and are willing to attend a 5-year visit and provide medical records.
Not a fit: People considering ESG but who have not had the procedure, those treated with a different device or without the required follow-up data, are unlikely to benefit directly from this observational follow-up.
Why it matters
Potential benefit: If successful, the results could clarify how durable weight loss is after ESG and help patients and clinicians make informed long-term treatment choices.
How similar studies have performed: Shorter-term studies (1–2 years) of ESG have shown meaningful weight loss, but robust five-year outcome data are limited, so this follow-up provides relatively novel long-term information.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Evanston, Illinois and 7 other locations
- Endeavor Health Evanston Hospital — Evanston, Illinois, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Bellaire, Texas, United States (Recruiting)
- The BMI Clinic — Double Bay, New South Wales, Australia (Not_yet_recruiting)
- CHU de Strasbourg, IHU-Strasbourg — Strasbourg, France (Not_yet_recruiting)
- Mohak hi-tech Specialty Hospital — Indore, Madhya Pradesh, India (Not_yet_recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Not_yet_recruiting)
- New You Medical Center — Riyadh, Saudi Arabia (Not_yet_recruiting)
- Spire Southampton — Southampton, Hampshire, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Maxime Oriol
- Email: maxime.oriol@bsci.com
- Phone: 978-790-8009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.