Status:
COMPLETED
Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
EndoVx, Inc.
University of California, San Francisco
Conditions:
Morbid Obesity
Eligibility:
All Genders
25-55 years
Phase:
NA
Brief Summary
This two site study will evaluate the safety and effectiveness of laparoscopic truncal vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.
Detailed Description
30 morbidly obese patients evenly enrolled at The University of California San Francisco and at the University of Rochester will be selected for study on a voluntary basis. They will have a BMI of \>3...
Eligibility Criteria
Inclusion
- male or female age 25-55
- BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity
- Stable weight for the last 3 months
- willing to use contraceptives
- motivated to lose weight
- a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight
- fully ambulatory
Exclusion
- sign of prior major abdominal surgery
- history of or signs and /or symptoms of gastro-duodenal ulcer disease
- abnormal vagus nerve testing
- current use of a list of medication
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00285220
Start Date
September 1 2005
End Date
December 1 2008
Last Update
February 19 2009
Active Locations (2)
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1
University of California at San Francisco, Dept of Pediatrics
San Francisco, California, United States, 94143
2
Strong Health Bariatric Center at Highland Hospital
Rochester, New York, United States, 14624