Recruiting

TORe & Lifestyle Modification

Sponsor:

Boston Scientific Corporation

Code:

NCT07015424

Conditions

Weight Regain

Weight Loss

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TORe with OverStitch

Intensive lifestyle modification

Study Details

Brief summary:

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.

Conditions

Weight Regain

Weight Loss

Study ID

NCT07015424

Start date

Apr 14, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years or older.
  • 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 use or use within the three months prior to the baseline visit of over the counter or prescribed weight loss supplements / medications (including incretins).
  • 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.

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Victoria Lazzari

508-561-7296victoria.lazzari@bsci.com

Locations

Hoag Memorial Hospital

Recruiting

Irvine, California, United States, 92618

Contacts

Laurie Hendricks

laurie.hendricks@hoag.org

Principal Investigator:

Jennifer Phan, MD

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Kim Hall

Hall.Kimberly@mayo.edu

Principal Investigator:

Victoria Gomez, MD

Orlando Health Inc

Recruiting

Orlando, Florida, United States, 32806

Contacts

Leticia Morales

Leticia.Morales@orlandohealth.com

Principal Investigator:

Andre Teixeira, MD

Mayo Clinic Foundation

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Liz Lemke

lemke.elizabeth@mayo.edu

Principal Investigator:

Eric J Vargas Valls, MD

University of Texas Houston Health Science Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Angielyn Rivera

Angielyn.r.rivera@uth.tmc.edu

Principal Investigator:

Erik Wilson, MD

More Information

Sponsor

Boston Scientific Corporation

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • TORe
  • OverStitch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Boston Scientific Corporation on 2026-08-19.