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

NCT06894498 | Recruiting

• 1 other identifier: E1754
• Study Type: observational
• Target: 100
• Locations: 7 countries
• Sites: 8

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.

Conditions

Weight Loss; Obesity and Obesity-related Medical Conditions

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects that maintain clinically significant weightloss at five-year visit

  Mean % Total Body Weight Loss (TBWL) at 5-year visit.

  TBWL assessed at five-years post ESG

Interventions

No Intervention: Observational Cohort OTHER

No Intervention, Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from weight loss or bariatric centers

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (8)

Endeavor Health Evanston Hospital

Evanston, Illinois, 60201, United States

RECRUITING

The University of Texas Health Science Center at Houston

Bellaire, Texas, 77401, United States

RECRUITING

The BMI Clinic

Double Bay, New South Wales, 2028, Australia

NOT YET RECRUITING

CHU de Strasbourg, IHU-Strasbourg

Strasbourg, 67000, France

NOT YET RECRUITING

Mohak hi-tech Specialty Hospital

Indore, Madhya Pradesh, 453555, India

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

NOT YET RECRUITING

New You Medical Center

Riyadh, 11671, Saudi Arabia

NOT YET RECRUITING

Spire Southampton

Southampton, Hampshire, SO16 6UY, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Maxime Oriol

CONTACT

978-790-8009; maxime.oriol@bsci.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

IT (1); US (2); IN (1); AU (1); SA (1); GB (1); FR (1)