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

Launched by BOSTON SCIENTIFIC CORPORATION · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term effects of a procedure called Endoscopic Sleeve Gastroplasty (ESG) on weight loss. ESG is a minimally invasive treatment that helps people lose weight and improve related health conditions. The study aims to understand how patients who had this procedure more than five years ago have maintained their weight loss and what their journey has been like since then.

To participate, individuals must be at least 18 years old and have a body mass index (BMI) between 30 and 50, which indicates obesity. Participants should have completed at least one follow-up appointment after their ESG procedure, and they must be willing to attend one more appointment for the study. There are no specific exclusions, so if you meet the age and BMI criteria and have kept up with your follow-up visits, you could be eligible. If you join the study, you can expect to share your experiences and have your progress assessed to help researchers understand the long-term benefits of ESG.

Gender

ALL

Eligibility 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