Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
|ClinicalTrials.gov Identifier: NCT00527644|
Recruitment Status : Terminated (Insufficient funding to complete study)
First Posted : September 11, 2007
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment|
|Healthy||Device: 5mm spring clip|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of Spring-Type Laparoscopic Clip Technology|
|Study Start Date :||July 2007|
|Primary Completion Date :||September 2008|
|Study Completion Date :||September 2008|
Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
Device: 5mm spring clip
Microline Pentax 5mm Visu-Loc Clip Applier
- No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan. [ Time Frame: By post op day one HIDA scan. ]
- 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. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527644
|United States, Missouri|
|University of Missouri Hospital and Clinics|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Bruce Ramshaw, MD||Chief, Division of General Surgery|