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Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

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ClinicalTrials.gov Identifier: NCT00527644
Recruitment Status : Terminated (Insufficient funding to complete study)
First Posted : September 11, 2007
Results First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Device: 5mm spring clip Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Spring-Type Laparoscopic Clip Technology
Study Start Date : July 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • Inflammatory bowel disease (IBD)
  • Ulcerative colitis (UC)
  • Receiving steroids
  • Severe chronic obstructive pulmonary disease (COPD) or pulmonary disorder
  • History of connective tissue disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527644


Locations
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United States, Missouri
University of Missouri Hospital and Clinics
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Bruce Ramshaw, MD Chief, Division of General Surgery
More Information
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Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00527644    
Other Study ID Numbers: 1090979
First Posted: September 11, 2007    Key Record Dates
Results First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017
Keywords provided by University of Missouri-Columbia:
biliary leaks after laparoscopic cholecystectomy
Additional relevant MeSH terms:
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Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action