Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
NCT ID: NCT01343160
Last Updated: 2021-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
43 participants
INTERVENTIONAL
2011-04-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GORE VIABIL® Biliary Endoprosthesis
Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency
GORE® VIABIL® Biliary Endoprosthesis
Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture
Interventions
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GORE® VIABIL® Biliary Endoprosthesis
Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture
Eligibility Criteria
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Inclusion Criteria
* Subject is ≥18 years of age
* Subject is able to comply with study protocol and follow-up requirements
* Written informed consent is obtained using the Investigational Review Board (IRB)/Ethics Committee (EC) approved consent form
Exclusion Criteria
* Treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent
* The subject has malignant biliary disease
* Subject has known pregnancy
* Participated in protocol involving investigational drug or device within 90 days prior to entry into this study
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Karel Caca, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Ludwigsburg
Locations
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Klinikum Ludwigsburg
Ludwigsburg, , Germany
Countries
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Other Identifiers
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VBR CS 156
Identifier Type: -
Identifier Source: org_study_id
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