Randomized Trial on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass
108
about 2.8 years
18+
9 sites in CA, FL, IL +3
Why this study is shown
What this study is about
This trial is testing if a procedure called TORe, combined with lifestyle changes, helps people regain weight after gastric bypass surgery compared to just lifestyle changes alone. Participants will be randomly assigned to either receive the TORe procedure along with intensive lifestyle modifications or only undergo intensive lifestyle changes.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Participate in Intensive lifestyle modification
- 2.Use TORe with OverStitch
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Total Body Weight Loss
Secondary: Change in 36-Item Short Form Survey (SF-36) Quality of Life Questionnaire, Change in A1C, Change in Alanine transaminase (ALT), Change in Aspartate aminotransferase (AST), Change in Impact of Weight on Quality of Life (IWQOL LITE-CT) Quality of Life Questionnaire, Change in Triglycerides, Number of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Endocrinology