108
Participants
Start Date
November 30, 2025
Primary Completion Date
February 28, 2027
Study Completion Date
September 30, 2029
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.
NYU Grossman School of Medicine, New York
Mayo Clinic, Jacksonville
Orlando Health Inc, Orlando
University of South Florida, Tampa
Mayo Clinic Foundation, Rochester
Rush University Medical Center, Chicago
University of Texas Houston Health Science Center, Houston
Hoag Memorial Hospital, Irvine
Stanford University Medical Center, Stanford
Brigham and Women's Hospital, Boston
Lead Sponsor
Boston Scientific Corporation
INDUSTRY