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Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00527644
First received: September 7, 2007
Last updated: August 4, 2016
Last verified: August 2016

September 7, 2007
August 4, 2016
July 2007
September 2008   (final data collection date for primary outcome measure)
No leak, subclinical leak or clinical bile leak on post-operative HIDA scan. [ Time Frame: By post op day one HIDA scan. ] [ Designated as safety issue: Yes ]
No leak, subclinical leak or clinical bile leak on post-operative HIDA scan. [ Time Frame: By post op day one HIDA scan. ]
Complete list of historical versions of study NCT00527644 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
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. ]
Not Provided
Not Provided
 
Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
The Visu-Loc spring clip is being used to occlude the cystic duct at the time of laparoscopic cholecystectomy. A HIDA scan will be completed on post operative day one to check for biliary leaks.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy
Device: 5mm spring clip
Microline Pentax 5mm Visu-Loc Clip Applier
Other Names:
  • Visu-Loc Clip Applier
  • FDA Regulation Number: 21 CFR 878.4300
  • FDA Regulation Name: Implantable Clip
  • FDA Regulatory Class: II
Spring Clips
Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.
Intervention: Device: 5mm spring clip
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
September 2008
September 2008   (final data collection date for primary outcome measure)

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
  • IBD (inflammatory bowel disease)
  • UC (ulcerative colitis)
  • Receiving steroids
  • Severe COPD or pulmonary disorder
  • History of connective tissue disorder
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00527644
1090979
No
Not Provided
Not Provided
University of Missouri-Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Bruce Ramshaw, MD Chief, Division of General Surgery
University of Missouri-Columbia
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP