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

Boston Scientific

Status: Not yet enrolling

Conditions: Weight Loss; Obesity and Obesity-related Medical Conditions

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Industry

Identifiers

NCT06894498

E1754

Details and patient eligibility

About

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.

Full description

Includes retrospective data collection and one prospective visit

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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