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

Last updated: March 11, 2026
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Diabetes Prevention

Obesity

Treatment

No Intervention: Observational Cohort

Clinical Study ID

NCT06894498
E1754
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 theprimary 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 forweight loss management (visit can be collected either retrospectively orprospectively)

  • Subject has returned for a minimum of one annual follow-up at the treating site forweight loss management annually between two and four years from the procedure.

  • Subject is willing to complete one prospective visit (5 year or 5+ year, asappropriate)

  • Subject is able to read, understand, and sign a written Informed Consent Form toparticipate in the study

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: No Intervention: Observational Cohort
Phase:
Study Start date:
March 01, 2026
Estimated Completion Date:
December 31, 2026

Study Description

Includes retrospective data collection and one prospective visit

Connect with a study center

  • The BMI Clinic

    Double Bay, New South Wales 2028
    Australia

    Site Not Available

  • The BMI Clinic

    Double Bay 8348524, New South Wales 2155400 2028
    Australia

    Site Not Available

  • CHU de Strasbourg, IHU-Strasbourg

    Strasbourg, 67000
    France

    Site Not Available

  • CHU de Strasbourg, IHU-Strasbourg

    Strasbourg 2973783, 67000
    France

    Site Not Available

  • Mohak hi-tech Specialty Hospital

    Indore, Madhya Pradesh 453555
    India

    Site Not Available

  • Mohak hi-tech Specialty Hospital

    Indore 1269743, Madhya Pradesh 1264542 453555
    India

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome 3169070, 00168
    Italy

    Site Not Available

  • New You Medical Center

    Riyadh, 11671
    Saudi Arabia

    Site Not Available

  • New You Medical Center

    Riyadh 108410, 11671
    Saudi Arabia

    Site Not Available

  • Spire Southampton

    Southampton, Hampshire SO16 6UY
    United Kingdom

    Site Not Available

  • Spire Southampton

    Southampton 2637487, Hampshire SO16 6UY
    United Kingdom

    Site Not Available

  • Endeavor Health Evanston Hospital

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • Endeavor Health Evanston Hospital

    Evanston 4891382, Illinois 4896861 60201
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

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