NCT01429194

The ACE Follow-up Study

Continuation of Follow-up for Patients Who Were Previously Enrolled in the Clinical Study: "Open Prospective Study to Evaluate the Safety and Preliminary Effectiveness of the BaroSense ACE Stapler for the Treatment of Obesity - (Protocol 11-03)."

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The 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.

Detailed description

This study was originally sponsored by BaroSense, Inc (protocol 11-03). 69 subjects were enrolled and treated as part of the study at 6 centers in 4 countries outside the United States. On April 30, 2013 BaroSense Inc went out of business and the study was terminated with all participating centers' Ethics Committees. At the point of study termination, all patients were in the middle of post procedure follow-up. Boston Scientific has since acquired the technology and study and will re-initiate follow-up to 24 months in order to collect data to support the original safety and efficacy endpoints of the protocol. Only the 69 subjects previously enrolled and treated in BaroSense's protocol 11-03 will be eligible for participation in the Boston Scientific continued follow-up study ("The ACE Follow-up Study" protocol 90891629). The Boston Scientific protocol will be approved by participating centers' Ethics Committees and patients who choose to participate in The ACE Follow-up Study will need to sign a new, Ethics Committee Approved, informed consent form.

Conditions

• Obesity

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-09-07
• Last updated: 2015-06-16

Locations

6 sites across 4 countries: Argentina, Canada, Israel, Netherlands