Status:
COMPLETED
Multi-Center Pre-Bariatric Weight Loss Study
Lead Sponsor:
Morphic Medical Inc.
Conditions:
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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.
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...
Eligibility Criteria
Inclusion
- BMI \> 35 with a significant comorbid condition or BMI 40-60
- Candidate for Bariatric Surgery
Exclusion
- No pathologies of the GI Tract
- No anti-coagulant or non-steroidal anti-inflammatory medications
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00469391
Start Date
June 1 2007
End Date
October 1 2008
Last Update
February 15 2017
Active Locations (4)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331
2
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
3
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
4
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232