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

NCT01388673 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-02-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • BaroSense Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388673 on ClinicalTrials.gov