Study for Short Term Weight Loss in Candidates for Bariatric Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT00985491
First received: September 25, 2009
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Obesity
Device: Endobarrier Liner
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Assessment of % excess weight loss [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in Type 2 Diabetic status [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
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)
Arms Assigned Interventions
Experimental: Device
All patients will be implanted with the Endobarrier Liner device.
Device: Endobarrier Liner
Medical device placed endoscopically in the duodenum
Other Name: GI Sleeve

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985491

Locations
Chile
Dr. Alex P. Escalona
Santiago, Chile
Sponsors and Collaborators
GI Dynamics
Investigators
Principal Investigator: Alex P Escalona, MD Pontificia Universidad Catolica de Chile, Santiago, Chile
  More Information

No publications provided by GI Dynamics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT00985491     History of Changes
Other Study ID Numbers: 08-1
Study First Received: September 25, 2009
Last Updated: December 18, 2012
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

Keywords provided by GI Dynamics:
obesity

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 21, 2014