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

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

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.

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