RecruitingNCT06894498
Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss
Sponsor
Boston Scientific Corporation
Enrollment
100 participants
Start Date
Mar 1, 2026
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria1
- None
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Interventions
OTHERNo Intervention: Observational Cohort
No Intervention, Observational Cohort
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT06894498
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