Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
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|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||Phase|
|Healthy||Device: 5mm spring clip||Not Applicable|
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|
|Actual Primary Completion Date :||September 2008|
|Actual 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|