Multi-Center Pre-Bariatric Weight Loss Study

This study has been completed.
Sponsor:
Information provided by:
GI Dynamics
ClinicalTrials.gov Identifier:
NCT00469391
First received: May 3, 2007
Last updated: August 5, 2010
Last verified: August 2010

May 3, 2007
August 5, 2010
June 2007
October 2008   (final data collection date for primary outcome measure)
Weight Loss [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Weight Loss
Complete list of historical versions of study NCT00469391 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Obesity
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00469391
06-3
No
Keith Gersin, MD/Principal Investigator, Carolinas Medical Center 704-614-4253
GI Dynamics
Not Provided
Study Director: Michael Tarnoff, MD Tufts Medical Center
GI Dynamics
August 2010

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