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

W.L. Gore & Associates

Status: Completed

Conditions: Biliary Strictures

Treatments: Device: GORE® VIABIL® Biliary Endoprosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT01343160

VBR CS 156

Details and patient eligibility

About

The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

GORE VIABIL® Biliary Endoprosthesis

Other group

Description:

Placement of GORE VIABIL® Biliary Endoprosthesis to establish duct patency

Treatment:

Device: GORE® VIABIL® Biliary Endoprosthesis