NCT00527644

Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic cholecystectomy. A hepato-iminodiacetic acid (HIDA) scan will be completed on post operative day one to check for biliary leaks.

Detailed description

The purpose of this study is to evaluate how effective the Visu-Lock clip is at preventing leakage of bile (liquid made by liver and stored in gall bladder) after gallbladder surgery. It is not known if the Visu-Lock clip stops leaks better than other clips that have been used during gallbladder surgery. 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	5mm spring clip	Microline Pentax 5mm Visu-Loc Clip Applier

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-09-11
• Last updated: 2017-12-06
• Results posted: 2017-12-06

Locations

1 site across 1 country: United States