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Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

This study has been completed.
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00527644
First received: September 7, 2007
Last updated: March 9, 2010
Last verified: March 2010
History of Changes
  Purpose

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.

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.


Condition Intervention Phase
Healthy
 Device: 5mm spring clip
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527644

Locations
United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Bruce Ramshaw, MD Chief, Division of General Surgery
  More Information

No publications provided

Responsible Party: Klaus Thaler, MD, Department of General Surgery at University of Missouri, Columbia
ClinicalTrials.gov Identifier: NCT00527644     History of Changes
Other Study ID Numbers: 1090979
Study First Received: September 7, 2007
Last Updated: March 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
biliary leaks after laparoscopic cholecystectomy

ClinicalTrials.gov processed this record on May 23, 2013