Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
NCT ID: NCT07015424
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
108 participants
INTERVENTIONAL
2026-01-31
2028-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TORe and Lifestyle Modification Arm
Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study
TORe with OverStitch
Transoral Outlet Reduction with OverStitch Endoscopic Suturing System
Intensive lifestyle modification
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.
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.
Intensive lifestyle modification
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.
Interventions
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TORe with OverStitch
Transoral Outlet Reduction with OverStitch Endoscopic Suturing System
Intensive lifestyle modification
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.
Eligibility Criteria
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Inclusion Criteria
* Experiencing weight regain (≥ 20% weight from nadir) after achieving clinically successful weight loss.
* Willing to have a TORe procedure for the treatment of weight regain.
* BMI between 30 and 50 kg/m2, inclusive.
* GJA diameter ≥ 20 mm, confirmed either during a
* Screening EGD completed ≤ 60 days from study procedure or
* EGD performed immediately prior to the TORe procedure.
* Anatomically accepting of the procedure, including a pouch size that will not require reduction at the time of treatment (pouch that is shorter than 6 cm in length).
* Agrees not to take additional over the counter or prescribed weight loss supplements / medications (including incretins) during the first 6 months of the study.
* Is on a stable dose of anti-diabetic medication for three months with no anticipated changes during the first 6 months of the study.
* Agrees to the follow-up requirements of the study and is able to read, understand, and sign a written Informed Consent Form to participate in the study.
* Meets the indications for TORe procedure with OverStitch™ Endoscopic Suturing System.
Exclusion Criteria
* Current or planned management of Type 2 Diabetes with incretin medications.
* Inability or unwillingness to comply with assigned treatment or protocol requirements related to visits.
* Investigator's medical judgement that the subject is not a candidate for the TORe procedure.
* Current pregnancy confirmed by site standard of care or planned pregnancy or breastfeeding in the next two years.
* Vulnerable subject.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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Hoag Memorial Hospital
Irvine, California, United States
Stanford University Medical Center
Stanford, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Orlando Health Inc
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic Foundation
Rochester, Minnesota, United States
NYU Grossman School of Medicine
New York, New York, United States
University of Texas Houston Health Science Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Laurie Hendricks
Role: primary
Anisha Abreo
Role: primary
Kim Hall
Role: primary
Leticia Morales
Role: primary
Ilexsius Fiorillo
Role: primary
Amanda Lin
Role: primary
Michele Ryan
Role: primary
Liz Lemke
Role: primary
Valeria Pasuizaca
Role: primary
Angielyn Rivera
Role: primary
Other Identifiers
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E7220
Identifier Type: -
Identifier Source: org_study_id