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Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

This study has been terminated.
(Insufficient funding to complete study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527644
First Posted: September 11, 2007
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Missouri-Columbia
September 7, 2007
September 11, 2007
October 24, 2017
December 6, 2017
December 6, 2017
July 2007
September 2008   (Final data collection date for primary outcome measure)
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. ]
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. ]
Same as current
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 hepato-iminodiacetic acid (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
Not Provided
Intervention Model: Single Group Assignment
Masking: None (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.
 
Terminated
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
  • Inflammatory bowel disease (IBD)
  • Ulcerative colitis (UC)
  • Receiving steroids
  • Severe chronic obstructive pulmonary disease (COPD) or pulmonary disorder
  • History of connective tissue disorder
Sexes Eligible for Study: All
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
November 2017

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