Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for the Treatment of Obesity
The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational system using endoscopic guidance to trans-orally place plications in the stomach in obese subjects to reduce volume and expansion of the fundus and greater curve to abate hunger as part of a supervised weight reduction program.
The primary objective of this study is to perform an evaluation of the safety of the plication procedure.
The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of obesity over a 24 month follow-up period.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open, Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACETM Stapler for the Treatment of Obesity|
- Proportion of participants with adverse events [ Time Frame: Post-procedure through 24 months ] [ Designated as safety issue: Yes ]The primary safety analysis will assess the occurrence of adverse events through 24 months after the plication procedure. Included in this assessment will be the proportion of subjects with any of the following outcomes between enrollment and completion of the 24 month follow-up evaluation: Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
- Percent excess weight loss in participants relative to preop weight [ Time Frame: Through 24 months post-procedure ] [ Designated as safety issue: No ]
Effectiveness measurements will be analyzed relative to baseline. The collected measures will include:
- Percent excess weight loss (%EWL), defined as: (preop weight-current weight)/(preop weight - ideal weight) *100, where ideal weight is the weight that would correspond to a BMI of 25 based on the subject's height.
- Total weight lost (kg) and percent weight lost
- Change in waist circumference
- Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: ACE procedure
ACE procedure for the treatment of obesity
Procedure: BaroSense ACE Stapler
The ACE Stapler is used endoscopically, and incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.