Multi-Center Pre-Bariatric Weight Loss Study
This study has been completed.
Sponsor:
GI Dynamics
Information provided by:
GI Dynamics
ClinicalTrials.gov Identifier:
NCT00469391
First received: May 3, 2007
Last updated: August 5, 2010
Last verified: August 2010
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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:
- Weight Loss [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 69 |
| 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 |
| 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
| Responsible Party: | Keith Gersin, MD/Principal Investigator, Carolinas Medical Center 704-614-4253 |
| ClinicalTrials.gov Identifier: | NCT00469391 History of Changes |
| Other Study ID Numbers: | 06-3 |
| Study First Received: | May 3, 2007 |
| Last Updated: | August 5, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GI Dynamics:
|
Weight Reduction |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 23, 2013