Obesity and Obesity-related Medical C...

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

Sponsored by Boston Scientific Corporation

About this trial

Last updated 10 days ago

Study ID

E1754

Status

Recruiting

Type

Observational

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 2 months ago

What is this trial 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.

What are the participation requirements?

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