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

August 28, 2026 updated by: Boston Scientific Corporation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Other: No Intervention: Observational Cohort

Detailed Description

Includes retrospective data collection and one prospective visit

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Evanston, Illinois, United States, 60201
    - Endeavor Health Evanston Hospital
- Texas
  - Bellaire, Texas, United States, 77401
    - The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Study participants will be selected from weight loss or bariatric centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects that maintain clinically significant weightloss at five-year visit Time Frame: TBWL assessed at five-years post ESG	Mean % Total Body Weight Loss (TBWL) at 5-year visit.	TBWL assessed at five-years post ESG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2026

Primary Completion (Actual)

July 30, 2026

Study Completion (Actual)

July 30, 2026

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria