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Clinical Evaluation of Spring-Type Laparoscopic Clip Technology

NCT ID: NCT00527644

Last Updated: 2017-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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biliary leaks after laparoscopic cholecystectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Spring Clips

Subjects will undergo laparoscopic cholecystectomy with commercially available 5 mm spring clips utilized for the ligation of the cystic duct and artery.

Group Type OTHER

5mm spring clip

Intervention Type DEVICE

Microline Pentax 5mm Visu-Loc Clip Applier

Interventions

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5mm spring clip

Microline Pentax 5mm Visu-Loc Clip Applier

Intervention Type DEVICE

Other Intervention Names

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Visu-Loc Clip Applier FDA Regulation Number: 21 CFR 878.4300 FDA Regulation Name: Implantable Clip FDA Regulatory Class: II

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce Ramshaw, MD

Role: PRINCIPAL_INVESTIGATOR

Chief, Division of General Surgery

Locations

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University of Missouri Hospital and Clinics

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1090979

Identifier Type: -

Identifier Source: org_study_id