Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TORe with OverStitch
DeviceTransoral Outlet Reduction with OverStitch Endoscopic Suturing System
Intensive lifestyle modification
BehavioralIntensive 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.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: TORe and Lifestyle Modification ArmActive comparator 2 interventions
Group B: Lifestyle Modification ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total Body Weight Loss
The percent TBWL that subjects achieve at 6 months post-randomization
Time frame
6 Months post enrollmentSecondary outcomes
1
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 enrollment2
Percent TBWL at each visit
Percent TBWL at each visit
Time frame
6 months post enrollment and through end of study3
Change in A1C
Change in Hemoglobin A1C from baseline
Time frame
6, 12, 18, and 24 months post enrollment4
Change in Insulin
Change in Insulin from baseline
Time frame
6, 12, 18, and 24 months post enrollmentSponsors and contacts
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Source ClinicalTrials.gov