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Recruiting NCT06894498

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

Trial Parameters

Condition Obesity and Obesity-related Medical Conditions
Sponsor Boston Scientific Corporation
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-03
Completion 2026-12
Interventions
No Intervention: Observational Cohort

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.

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

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