Multi-Center Pre-Bariatric Weight Loss Study

This study has been completed.

First Received: May 3, 2007 Last Updated: August 8, 2008 History of Changes

Sponsored by:	GI Dynamics
Information provided by:	GI Dynamics
ClinicalTrials.gov Identifier:	NCT00469391

Purpose

The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.

Condition	Intervention	Phase
Obesity	Device: GI Sleeve Implantable weight loss device	Phase II

MedlinePlus related topics: Obesity Surgery Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment
Official Title:	A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss

Further study details as provided by GI Dynamics:

Primary Outcome Measures:

Weight Loss

Study Start Date:

June 2007

Detailed Description:

This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.

Eligibility

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

Criteria

Inclusion Criteria:

BMI > 35 with a significant comorbid condition or BMI 40-60
Candidate for Bariatric Surgery

Exclusion Criteria:

No pathologies of the GI Tract
No anti-coagulant or non-steroidal anti-inflammatory medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469391

Locations

United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Massachusetts
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232

Sponsors and Collaborators

GI Dynamics

Investigators

Study Director:

Michael Tarnoff, MD

Tufts Medical Center

More Information

No publications provided

Study ID Numbers:	06-3
Study First Received:	May 3, 2007
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00469391 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GI Dynamics:

Weight Reduction

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 06, 2009