Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stap… (NCT01388673) | Clinical Trial Compass
WithdrawnNot Applicable
Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for Plication of Dilated Post-surgical Gastric Anatomy
0Started 2011-10
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Subject, male or female, is age 18 to 60 years of age.
✓. Subject must be able to understand and be willing to sign an informed consent document.
✓. Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
✓. Subject must be \> 2 years post RYGB surgery.
✓. Subject must have documented records indicating an initial achievement of \> 60% EWL (based on an ideal weight of 25 BMI) at some point after RYGB surgery.
✓. Subject has a BMI at baseline of \> 30 and \< 50.
✓. At time of enrollment, subject must have regained at least 35% of the maximum weight lost following RYGB, and the weight regain must have occurred over a period of not less than 3 months from the point of maximum weight loss.
✓. Subject must have a stoma diameter of at least 18 mm.
Exclusion criteria
✕. Subject has a severe eating disorder.
✕. Investigator determines that there is another causal factor for the subject's weight regain other than dilated gastric anatomy.
✕. Subject has previously undergone an endoscopic or surgical repair of dilated pouch or stoma (including sclerotherapy treatments).