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

Boston Scientific

Status: Completed

Conditions: Biliary Strictures Caused by Malignant Neoplasms

Treatments: Device: WallFlex™ Biliary Partially-Covered Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713427

ENDO-WALLFLEX-BIL-PALL-002

E7020

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

WallFlex Stent

Other group

Description:

All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.

Treatment:

Device: WallFlex™ Biliary Partially-Covered Stent