Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

Healthy Clinical Trial

Official title:

Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00527644
• Other study ID #: 1090979
• Status: Terminated
• Phase: N/A
• First received: September 7, 2007
• Last updated: November 28, 2017
• Start date: July 2007
• Est. completion date: September 2008

Study information

• Verified date: November 2017
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• 5mm spring clip
Microline Pentax 5mm Visu-Loc Clip Applier

Locations

Country	Name	City	State
United States	University of Missouri Hospital and Clinics	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.		By post op day one HIDA scan.
Secondary	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.