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Safety and Preliminary Effectiveness of the BaroSense Articulating Circular Endoscopic (ACE) Stapler for Plication of Dilated Post-surgical Gastric Anatomy

Obese Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01388673
Study type Interventional
Source BaroSense Inc.
Contact
Status Withdrawn
Phase N/A
Start date October 2011
Completion date February 2013
View Details
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