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

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

The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.

Inclusion Criteria:

• Age 18 or older
• Clinical symptoms of biliary obstruction
• Inoperable extrahepatic biliary obstruction by any malignant process
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

• Participation in an Investigational Study within 90 days prior to date of patient consent
• Strictures that cannot be dilated enough to pass the delivery system
• Perforation of any duct within the biliary tree
• Presence of a metal biliary stent
• Presence of any esophageal or duodenal stent
• Patients for whom endoscopic procedures are contraindicated
• Patients with known sensitivity to any components of the stent or delivery system
• Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
• Patients with an anticipated life expectancy of < 3 months