Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285220
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2006-01-31
Brief Title:
Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
A Prospective Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 35 with at least one obesity related comorbidity or a BMI between 40 and 45 Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline
Thereafter they will undergo a laparoscopic truncal vagotomy Over 18 months post operative tests of adequate vagotomy weight loss change in body composition and metabolism will be studied
Thereafter they will undergo a laparoscopic truncal vagotomy Over 18 months post operative tests of adequate vagotomy weight loss change in body composition and metabolism will be studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None