Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic cholecystectomy. A HIDA scan will be completed on post operative day one to check for biliary leaks.
Null hypothesis: There is no difference in subclinical or clinical leak rate between spring and crush clips used for cystic duct ligation.
Alternative hypothesis: Titanium spring clips decrease the rate of subclinical or clinical biliary leak from the cystic duct stump after laparoscopic cholecystectomy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Clinical Evaluation of Spring-Type Laparoscopic Clip Technology|
- No leak, subclinical leak or clinical bile leak on post-operative HIDA scan. [ Time Frame: By post op day one HIDA scan. ] [ Designated as safety issue: Yes ]
- Any other evidence of biliary leak. Surgeon assessments of device use: ease of use , deployment and clip security. [ Time Frame: By post op day one HIDA scan. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Device: 5mm spring clip
- Visu-Loc Clip Applier
- FDA Regulation Number: 21 CFR 878.4300
- FDA Regulation Name: Implantable Clip
- FDA Regulatory Class: II
|United States, Missouri|
|University of Missouri Hospital and Clinics|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Bruce Ramshaw, MD||Chief, Division of General Surgery|