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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
  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.

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

Study Type: Interventional
Study Design: 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: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Spring Clips
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
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00527644     History of Changes
Other Study ID Numbers: 1090979 
Study First Received: September 7, 2007
Last Updated: August 4, 2016
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 September 26, 2016