Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

Conditions
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Healthy

Intervention / Treatment
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* Device: 5mm spring clip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult(18 or older) Diagnosis of cholelithiasis or cholecystitis Diagnosis of choledocholithiasis or biliary dyskinesia scheduled fo laparoscopic cholecystectomy Females: NOT pregnant Exclusion Criteria: Breastfeeding Malignancy Inflammatory bowel disease (IBD) Ulcerative colitis (UC) Receiving steroids Severe chronic obstructive pulmonary disease (COPD) or pulmonary disorder History of connective tissue disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spring Clips<br>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<br>* Microline Pentax 5mm Visu-Loc Clip Applier<br>* Other names: FDA Regulatory Class: II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan. |  | By post op day one HIDA scan. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Other Evidence of Biliary Leak. Surgeon Assessments of Device Use: Ease of Use , Deployment and Clip Security. |  | By post op day one HIDA scan. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biliary leaks after laparoscopic cholecystectomy