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

May 3, 2007
May 4, 2007
November 1, 2016
December 30, 2016
February 15, 2017
June 2007
October 2008   (Final data collection date for primary outcome measure)
Percent Excess Weight Loss (%EWL) at Week 12 [ Time Frame: 3 months ]
Excess Weight Loss was calculated using the Metropolitan Life Table (MET method)
Weight Loss
Complete list of historical versions of study NCT00469391 on Archive Site
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Multi-Center Pre-Bariatric Weight Loss Study
A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Device: GI Sleeve Implantable weight loss device (EndoBarrier)
    device for weight loss
    Other Name: endobarrier
  • Procedure: Sham Procedure
    Weight loss
    Other Name: Sham
  • Experimental: GI Sleeve
    medical device that mimics gastric bypass mechanism for weight-loss
    Intervention: Device: GI Sleeve Implantable weight loss device (EndoBarrier)
  • Sham Comparator: Sham Control
    Intervention: Procedure: Sham Procedure
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2008
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Plan to Share IPD: Undecided
Plan Description: De-identified individual patient data is on file at the Sponsor
GI Dynamics
GI Dynamics
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Study Director: Michael Tarnoff, MD Tufts Medical Center
GI Dynamics
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP