Study for Short Term Weight Loss in Candidates for Bariatric Surgery
The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery|
- Assessment of % excess weight loss [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Improvement in Type 2 Diabetic status [ Time Frame: 36 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||July 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
All patients will be implanted with the Endobarrier Liner device.
Device: Endobarrier Liner
Medical device placed endoscopically in the duodenum
Other Name: GI Sleeve
Patients with obesity are at significantly greater risk of developing significant co-morbid complications, and are associated with an increased risk in all-cause mortality. The GI Endobarrier Liner represents a viable alternative to other short-term weight loss methods. It is a minimally invasive endoscopic procedure, which may allow patients to recover faster with less morbidity and mortality. This study is investigating the safety and efficacy of the GI Endobarrier Liner in patients who are candidates for bariatric surgery.