Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

Inclusion Criteria:

• Age 18 years or older
• Inoperable extrahepatic biliary obstruction by any malignant process
• Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

• Participation in another invesitgational study within 90 days prior to date of patient consent.
• Strictures that cannot be dialated enough to pass the delivery system
• Perforation of any duct within the biliary tree
• Presence of any esophageal or duodenal stent
• Patients for whom endoscopic procedures are contraindicated
• Patients with known senesitivity to any components of the stent or delivery system
• Patients with active hepatitis