Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

November 28, 2017 updated by: University of Missouri-Columbia
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
By post op day one HIDA scan.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
By post op day one HIDA scan.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Bruce Ramshaw, MD, Chief, Division of General Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 7, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1090979

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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