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Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

This study has been completed.
Information provided by (Responsible Party):
University of Missouri-Columbia Identifier:
First received: September 7, 2007
Last updated: August 4, 2016
Last verified: August 2016
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: Intervention Model: Single Group Assignment
Masking: None (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. ]

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. ]

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00527644

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

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

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

Additional relevant MeSH terms:
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 20, 2017