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

Boston Scientific Corporation108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Weight Regain Weight Loss

Interventions

Intensive lifestyle modificationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Hoag Memorial Hospital

Irvine, California, United States

RECRUITING

Stanford University Medical Center

Stanford, California, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, United States

RECRUITING

Orlando Health Inc

Orlando, Florida, United States

RECRUITING

University of South Florida

Tampa, Florida, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

NOT_YET_RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

NOT_YET_RECRUITING

Mayo Clinic Foundation

Rochester, Minnesota, United States

RECRUITING

NYU Grossman School of Medicine

New York, New York, United States

RECRUITING

Northwell Health

New York, New York, United States

NOT_YET_RECRUITING

...and 2 more locations

Outcomes

Primary Outcomes

Total Body Weight Loss

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

Time frame: 6 Months post enrollment

Secondary Outcomes

Clinically significant weight loss

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.

Time frame: 6, 12 and 24 months post enrollment

Percent TBWL at each visit

Time frame: 6 months post enrollment and through end of study

Change in A1C

Change in Hemoglobin A1C from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in Insulin

Change in Insulin from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in Fasting Glucose

Change in Fasting Glucose from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in Cholesterol

Change in Total Cholesterol from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in LDL

Change in LDL from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in HDL

Change in HDL from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in Triglycerides

Change in Triglycerides from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in Alanine transaminase (ALT)

Change in ALT from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in Alkaline phosphatase (ALP)

Change in ALP from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in Aspartate aminotransferase (AST)

Change in AST from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Reduction in Medications for Type 2 diabetes

Reduction in Type 2 diabetes medication dose and frequency from Baseline

Time frame: 6, 12, 18 and 24 months post enrollment

Reduction in Hypertension Medication

Reduction in hypertension medication dose and frequency from Baseline

Time frame: 6, 12, 18 and 24 months post enrollment

Reduction in cholesterol medication

Reduction in cholesterol medication dose and frequency from Baseline

Time frame: 6, 12, 18 and 24 months post enrollment

Reduction in medications for dumping syndrome

Reduction in dumping syndrome medication dose and frequency from Baseline

Time frame: 6, 12, 18 and 24 months post enrollment

Number of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Time frame: From enrollment through 24 months (study completion)

Change in Impact of Weight on Quality of Life (IWQOL LITE-CT) Quality of Life Questionnaire

Change in IWQOL LITE-CT scores from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in 36-Item Short Form Survey (SF-36) Quality of Life Questionnaire

Change in SF-36 Questionnaire scores from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

Change in Sigstad Score

Change in Sigstad score from baseline

Time frame: 6, 12, 18, and 24 months post enrollment

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

Overview

Conditions

Interventions

Eligibility

Locations (12)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts