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Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343160
First Posted: April 27, 2011
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
W.L.Gore & Associates
  Purpose
Generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.

Condition Intervention
Biliary Strictures Device: GORE® VIABIL® Biliary Endoprosthesis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study of Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Successful treatment of benign stricture upon implant [ Time Frame: Upon implant ]

Enrollment: 43
Study Start Date: January 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
GORE VIABIL® Biliary Endoprosthesis
Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency
Device: GORE® VIABIL® Biliary Endoprosthesis
Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture

Detailed Description:
Primary outcome measure is patency at each follow up visit.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis
  • 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:

  • Subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region)
  • 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
  Contacts and Locations
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): NCT01343160


Locations
Germany
Klinikum Ludwigsburg
Ludwigsburg, Germany
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Karel Caca, MD Klinikum Ludwigsburg
  More Information

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01343160     History of Changes
Other Study ID Numbers: VBR CS 156
First Submitted: February 14, 2011
First Posted: April 27, 2011
Last Update Posted: October 14, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Constriction, Pathologic
Cholestasis
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases


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