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

May 5, 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

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Includes retrospective data collection and one prospective visit

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Double Bay, New South Wales, Australia, 2028
        • Not yet recruiting
        • The BMI Clinic
        • Contact:
        • Principal Investigator:
          • Adrian Sartoretto, MD
  • France
      • Strasbourg, France, 67000
        • Not yet recruiting
        • CHU de Strasbourg, IHU-Strasbourg
        • Contact:
        • Principal Investigator:
          • Silvana Perretta, MD
  • India
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 453555
        • Not yet recruiting
        • Mohak hi-tech Specialty Hospital
        • Principal Investigator:
          • Mohit Bhandari, MD
        • Contact:
  • Italy
      • Rome, Italy, 00168
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11671
        • Not yet recruiting
        • New You Medical Center
        • Contact:
        • Principal Investigator:
          • Aayed Alqahtani, Prof
  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6UY
        • Not yet recruiting
        • Spire Southampton
        • Contact:
        • Principal Investigator:
          • Jamie Kelly, BM, BSc, FRCS
  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • Endeavor Health Evanston Hospital
        • Principal Investigator:
          • Michael Ujiki, MD
        • Contact:
    • Texas
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Principal Investigator:
          • Erik Wilson, MD
        • Contact:

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

No

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 (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1754

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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