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

NCT07015424 | Recruiting FDA Device

• 1 other identifier: E7220
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 9

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

Keywords

TORe; OverStitch

Outcome Measures

Primary Outcomes (1)

• Total Body Weight Loss

  The percent TBWL that subjects achieve at 6 months post-randomization

  6 Months post enrollment

Secondary Outcomes (20)

• Clinically significant weight loss

  6, 12 and 24 months post enrollment

• Percent TBWL at each visit

  6 months post enrollment and through end of study

• Change in A1C

  6, 12, 18, and 24 months post enrollment

• Change in Insulin

  6, 12, 18, and 24 months post enrollment

• Change in Fasting Glucose

  6, 12, 18, and 24 months post enrollment

Study Arms (2)

TORe and Lifestyle Modification Arm

ACTIVE COMPARATOR

Subjects will receive a TORe procedure and intensive lifestyle modification throughout the study

Device: TORe with OverStitch; Behavioral: Intensive lifestyle modification

Lifestyle Modification Arm

ACTIVE COMPARATOR

Subjects will receive intensive lifestyle modification throughout the study. At 6 months post enrollment, subjects will be eligible to receive a TORe procedure.

Behavioral: Intensive lifestyle modification

Interventions

TORe with OverStitch DEVICE

Transoral Outlet Reduction with OverStitch Endoscopic Suturing System

TORe and Lifestyle Modification Arm

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.

Lifestyle Modification Arm; TORe and Lifestyle Modification Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (9)

Hoag Memorial Hospital

Irvine, California, 92618, United States

NOT YET RECRUITING

Stanford University Medical Center

Stanford, California, 94305, United States

NOT YET RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Orlando Health Inc

Orlando, Florida, 32806, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

NOT YET RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

RECRUITING

NYU Grossman School of Medicine

New York, New York, 10016, United States

NOT YET RECRUITING

University of Texas Houston Health Science Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Victoria Lazzari

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 11, 2025
• Study Start: April 14, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (9)