Status:
TERMINATED
Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy
Lead Sponsor:
Central Carolina Surgery, PA
Collaborating Sponsors:
EndoVx, Inc.
Conditions:
Morbid Obesity
Obstructive Sleep Apnea
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Laparoscopic Adjustable Gastric Banding (LAGB) is a gold standard in the surgical treatment of morbid obesity. We hypothesize that the addition of truncal vagotomy (cutting of nerves to the stomach) w...
Detailed Description
The patients will receive standard laparoscopic adjustable gastric banding treatment as well as truncal vagotomy. The vagus nerves will be cut just below the diaphragm using the same access ports that...
Eligibility Criteria
Inclusion
- Male or female patient between 18 to 60 years of age.
- Patient has body mass index (BMI) between 40 to 50 or a BMI between 35 to 40 with one or more co-morbidities , and a stable weight for the last 3 months (+ 3 kg).
- Female patients must be willing to use contraceptive methods during the course of the trial (18 months).
- Patient must be motivated to lose weight.
- Patient has a history of at least one professionally supervised 6 month attempt to lose weight or more than two serious attempts.
- Patient must be fully ambulatory.
- Patient is to sign and be given a copy of the written informed consent form. -
Exclusion
- History or signs of prior gastric or esophageal surgery
- History of or signs and/or symptoms of gastro-duodenal ulcer disease.
- Participation or plans for participation in another investigational study during the study period.
- Patients with large hiatal hernias. -
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00329862
Start Date
May 1 2006
End Date
May 1 2006
Last Update
November 15 2011
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