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

Not Applicable

Not yet recruiting

• Conditions: Weight Regain; Weight Loss

• Registration Number: NCT07015424
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-21
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Study Start: 2025-11
• Primary Completion: 2027-02
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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 ≤ 30 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 12 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 one month 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Body Weight Loss	6 Months post enrollment	The percent TBWL that subjects achieve at 6 months post-randomization

Secondary Outcome Measures

Name	Time	Method
Reduction in Medications for Type 2 diabetes	6, 12, 18 and 24 months post enrollment	Reduction in Type 2 diabetes medication dose and frequency from Baseline
Change in 36-Item Short Form Survey (SF-36) Quality of Life Questionnaire	6, 12, 18, and 24 months post enrollment	Change in SF-36 Questionnaire scores from baseline
Change in LDL	6, 12, 18, and 24 months post enrollment	Change in LDL from baseline
Change in HDL	6, 12, 18, and 24 months post enrollment	Change in HDL from baseline
Change in Triglycerides	6, 12, 18, and 24 months post enrollment	Change in Triglycerides from baseline
Reduction in Hypertension Medication	6, 12, 18 and 24 months post enrollment	Reduction in hypertension medication dose and frequency from Baseline
Reduction in cholesterol medication	6, 12, 18 and 24 months post enrollment	Reduction in cholesterol medication dose and frequency from Baseline
Reduction in medications for dumping syndrome	6, 12, 18 and 24 months post enrollment	Reduction in dumping syndrome medication dose and frequency from Baseline
Number of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs)	From enrollment through 24 months (study completion)	Continuous assessment of safety of TORe by summarizing the occurrence of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs) at all visits and overall.
Change in Sigstad Score	6, 12, 18, and 24 months post enrollment	Change in Sigstad score from baseline
Change in Cholesterol	6, 12, 18, and 24 months post enrollment	Change in Total Cholesterol from baseline
Change in Alkaline phosphatase (ALP)	6, 12, 18, and 24 months post enrollment	Change in ALP from baseline
Change in Fasting Glucose	6, 12, 18, and 24 months post enrollment	Change in Fasting Glucose from baseline
Clinically significant weight loss	6, 12 and 24 months post enrollment	The rate of subjects that achieve clinically significant weight loss (i.e. responders) at 6 months. Clinically significant weight loss is defined as ≥ 10% TBWL.
Change in Alanine transaminase (ALT)	6, 12, 18, and 24 months post enrollment	Change in ALT from baseline
Change in Aspartate aminotransferase (AST)	6, 12, 18, and 24 months post enrollment	Change in AST from baseline
Percent TBWL at each visit	6 months post enrollment and through end of study	Percent TBWL at each visit
Change in A1C	6, 12, 18, and 24 months post enrollment	Change in Hemoglobin A1C from baseline
Change in Insulin	6, 12, 18, and 24 months post enrollment	Change in Insulin from baseline
Change in Impact of Weight on Quality of Life (IWQOL LITE-CT) Quality of Life Questionnaire	6, 12, 18, and 24 months post enrollment	Change in IWQOL LITE-CT scores from baseline

Trial Locations

Locations (1)

University of South Florida; 🇺🇸 Tampa, Florida, United States