Weight Regain, Weight Loss
Conditions
Keywords
TORe, OverStitch
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.
Interventions
DEVICETORe with OverStitch
Transoral Outlet Reduction with OverStitch Endoscopic Suturing System
BEHAVIORALIntensive 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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Weight Loss | 6 Months post enrollment | The percent TBWL that subjects achieve at 6 months post-randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 Fasting Glucose | 6, 12, 18, and 24 months post enrollment | Change in Fasting Glucose from baseline |
| Change in Cholesterol | 6, 12, 18, and 24 months post enrollment | Change in Total Cholesterol 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 |
| Change in Alanine transaminase (ALT) | 6, 12, 18, and 24 months post enrollment | Change in ALT from baseline |
| Change in Alkaline phosphatase (ALP) | 6, 12, 18, and 24 months post enrollment | Change in ALP from baseline |
| Change in Aspartate aminotransferase (AST) | 6, 12, 18, and 24 months post enrollment | Change in AST from baseline |
| 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 |
| 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 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 |
| 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 Sigstad Score | 6, 12, 18, and 24 months post enrollment | Change in Sigstad score from baseline |
Countries
United States
Contacts
CONTACTAndrea Burbage
CONTACTVictoria Lazzari
Outcome results
None listed