Clinical trial NCT07015424: Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
Official title: Prospective, Randomized Clinical Study Evaluating Transoral Outlet Reduction (TORe) and Lifestyle Modification for Patients With Weight Regain Following Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Weight Regain
Weight Loss
Keywords: TORe
OverStitch
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Body Weight Loss
timeFrame: 6 Months post enrollment
Secondary outcomes:
measure: Clinically significant weight loss
timeFrame: 6, 12 and 24 months post enrollment
measure: Percent TBWL at each visit
timeFrame: 6 months post enrollment and through end of study
measure: Change in A1C
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in Insulin
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in Fasting Glucose
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in Cholesterol
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in LDL
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in HDL
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in Triglycerides
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in Alanine transaminase (ALT)
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in Alkaline phosphatase (ALP)
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in Aspartate aminotransferase (AST)
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Reduction in Medications for Type 2 diabetes
timeFrame: 6, 12, 18 and 24 months post enrollment
measure: Reduction in Hypertension Medication
timeFrame: 6, 12, 18 and 24 months post enrollment
measure: Reduction in cholesterol medication
timeFrame: 6, 12, 18 and 24 months post enrollment
measure: Reduction in medications for dumping syndrome
timeFrame: 6, 12, 18 and 24 months post enrollment
measure: Number of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From enrollment through 24 months (study completion)
measure: Change in Impact of Weight on Quality of Life (IWQOL LITE-CT) Quality of Life Questionnaire
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in 36-Item Short Form Survey (SF-36) Quality of Life Questionnaire
timeFrame: 6, 12, 18, and 24 months post enrollment
measure: Change in Sigstad Score
timeFrame: 6, 12, 18, and 24 months post enrollment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References: