Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass

Part of paid clinical trials in Irvine, California.

Sponsor
Boston Scientific Corporation
Study ID
NCT07015424
Status
Recruiting
Apply to this trial

Conditions

  • Weight Loss
  • Weight Regain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TORe with OverStitch — DEVICE
    Transoral Outlet Reduction with OverStitch Endoscopic Suturing System
  • Intensive lifestyle modification — BEHAVIORAL
    Intensive lifestyle modification program consists of the following: well-balanced calorie-restrictive diet, incorporation of exercise and coaching on lifestyle changes. The program should include personal discussions and goals designed and overseen by the treating physician, obesity management professional or dietician.

Study Details

The goal of this clinical trial is to evaluate weight loss with TORe and intensive lifestyle modification versus intensive lifestyle modification alone in subjects who have regained weight following a Roux-en-Y gastric bypass. Participants will randomized 2:1. Those randomized to the TORe arm will receive a TORe procedure and intensive lifestyle modification which consists of a well-balanced calorie restrictive diet, incorporation of exercise and coaching on lifestyle discussion. Participants randomized the lifestyle modification alone arm will be eligible to receive a TORe procedure at 6 months post enrollment. Total follow up will be 24 months.

Key Dates

First listed
Jun 11, 2025
Start date
Apr 14, 2026
Status verified
Sep 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: TORe and Lifestyle Modification Arm
    Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study
  • Active Comparator: Lifestyle Modification Arm
    Subjects will receive intensive lifestyle modification throughout the study. At 6 months post enrollment, subjects will be eligible to receive a TORe procedure.

Primary Outcome Measure

Total Body Weight Loss [ Time Frame: 6 Months post enrollment ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Hoag Memorial HospitalIrvineCalifornia92618
Laurie Hendricks
[email protected]
Jennifer Phan, MD (PRINCIPAL_INVESTIGATOR)
Stanford University Medical CenterStanfordCalifornia94305
Micaela Esquivel
[email protected]
Micaela Esquivel, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicJacksonvilleFlorida32224
Victoria Gomez, MD (PRINCIPAL_INVESTIGATOR)
Orlando Health IncOrlandoFlorida32806
Leticia Morales
[email protected]
Andre Teixeira, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33606
Avennette Pinto
[email protected]
Salvatore Docimo, DO (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Christopher Chapman, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287
Margaret "Geri" Keane, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic FoundationRochesterMinnesota55905
Eric J Vargas Valls, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthNew YorkNew York10075
Steven Shamah, MD (PRINCIPAL_INVESTIGATOR)
NYU Grossman School of MedicineNew YorkNew York10016
Valeria Pasuizaca
[email protected]
Rabia De Latour, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Houston Health Science CenterHoustonTexas77030
Angielyn Rivera
[email protected]
Erik Wilson, MD (PRINCIPAL_INVESTIGATOR)
West Virginia University HospitalMorgantownWest Virginia26506
Shailendra Singh, MD (PRINCIPAL_INVESTIGATOR)

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