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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014