Overview

This trial is active, not recruiting.

Condition obesity
Treatment endobarrier liner
Phase phase 2
Sponsor GI Dynamics
Start date October 2008
End date July 2016
Trial size 180 participants
Trial identifier NCT00985491, 08-1

Summary

The purpose of this study is to determine whether the GI Endobarrier Liner is safe and effective.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All patients will be implanted with the Endobarrier Liner device.
endobarrier liner GI Sleeve
Medical device placed endoscopically in the duodenum

Primary Outcomes

Measure
Assessment of % excess weight loss
time frame: 36 months

Secondary Outcomes

Measure
Improvement in Type 2 Diabetic status
time frame: 36 months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Age 18 to 55 - BMI >35 with co-morbidities, >40 <60 without - candidates for Roux-en-Y gastric bypass - patients who have failed on nonsurgical weight loss methods Exclusion Criteria: - subjects taking weight-loss medications - subjects with GERD - subjects with history of conditions of the GI tract - subjects with pancreatitis or other serious organic conditions - subjects with active H. Pylori infection

Additional Information

Official title A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery
Principal investigator Alex P Escalona, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by GI Dynamics.