Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for Plication of Dilated Post-surgical Gastric Anatomy
The BaroSense Articulating Circular Endoscopic (ACE) Stapler is an investigational instrument indicated for endoluminal trans-oral tissue approximation and ligation in the gastrointestinal tract. This study explores the specific application of tissue apposition in dilated post-surgical gastric anatomy such as observed in a dilated Roux-en-Y Gastric Bypass (RYGB) pouch.
The primary objective of this study is to perform an evaluation of the safety of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy.
The secondary objective of this study is to evaluate the preliminary efficacy of the ACE Stapler for the treatment of dilated post-surgical gastric anatomy over a 12 month follow-up period.
|Obese||Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for Plication of Dilated Post-surgical Gastric Anatomy|
- Proportion of participants with adverse events [ Time Frame: Post-procedure through 12 months ]The primary safety analysis will assess the occurrence of adverse events through 12 months following procedures. Included in this assessment will be the proportion of subjects with any of the following outcomes between enrollment and completion of the 12 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 12 months post-procedure ]
Efficacy measurements will be analyzed relative to the surgery visit. 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 calculated from a BMI of 25 based on the subject's height.
- Total weight lost (kg)
- Change in body mass index (BMI)
- 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:||October 2011|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: ACE Stapler procedure
ACE Stapler procedure for the treatment of dilated post-surgical gastric anatomy
Procedure: BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy
The ACE Stapler is used endoscopically, an incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.