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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01343160
First received: February 14, 2011
Last updated: September 23, 2013
Last verified: September 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: May 2015
Estimated 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
Other Name: GORE® VIABIL® Biliary Endoprosthesis

Detailed Description:

Primary outcome measure is patency at each follow up visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343160

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

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01343160     History of Changes
Other Study ID Numbers: VBR CS 156
Study First Received: February 14, 2011
Last Updated: September 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 15, 2014