Study for Short Term Weight Loss in Candidates for Bariatric Surgery

Obesity Clinical Trial

Official title:

A Pilot Trial of the GI EndoBarrier Liner for Short Term Weight Loss in Subjects Who Are Candidates for Bariatric Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00985491
• Other study ID #: 08-1
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 25, 2009
• Last updated: March 9, 2015
• Start date: October 2008
• Est. completion date: July 2016

Study information

• Verified date: December 2012
• Source: GI Dynamics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Endobarrier Liner
Medical device placed endoscopically in the duodenum

Locations

Country	Name	City	State
Chile	Dr. Nicholas Quezada	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
GI Dynamics

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of % excess weight loss		36 months	No
Secondary	Improvement in Type 2 Diabetic status		36 months	No