Multi-Center Pre-Bariatric Weight Loss Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00469391
Recruitment Status : Completed
First Posted : May 4, 2007
Results First Posted : December 30, 2016
Last Update Posted : February 15, 2017
Information provided by (Responsible Party):
GI Dynamics

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Device: GI Sleeve Implantable weight loss device (EndoBarrier) Procedure: Sham Procedure Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss
Study Start Date : June 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: GI Sleeve
medical device that mimics gastric bypass mechanism for weight-loss
Device: GI Sleeve Implantable weight loss device (EndoBarrier)
device for weight loss
Other Name: endobarrier
Sham Comparator: Sham Control Procedure: Sham Procedure
Weight loss
Other Name: Sham

Primary Outcome Measures :
  1. Percent Excess Weight Loss (%EWL) at Week 12 [ Time Frame: 3 months ]
    Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00469391

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
Study Director: Michael Tarnoff, MD Tufts Medical Center

Responsible Party: GI Dynamics Identifier: NCT00469391     History of Changes
Other Study ID Numbers: 06-3
First Posted: May 4, 2007    Key Record Dates
Results First Posted: December 30, 2016
Last Update Posted: February 15, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified individual patient data is on file at the Sponsor

Keywords provided by GI Dynamics:
Weight Reduction

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms