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Multi-Center Pre-Bariatric Weight Loss Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT00469391
First received: May 3, 2007
Last updated: December 29, 2016
Last verified: December 2016
  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 (EndoBarrier)
Procedure: Sham Procedure
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss

Resource links provided by NLM:


Further study details as provided by GI Dynamics:

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


Enrollment: 56
Study Start Date: June 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult)
Sexes Eligible for Study:   All
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
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: 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

Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT00469391     History of Changes
Other Study ID Numbers: 06-3
Study First Received: May 3, 2007
Results First Received: November 1, 2016
Last Updated: December 29, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on April 24, 2017