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

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Cholestasis, Extrahepatic

Treatments: Device: WallFlex™ Biliary Fully Covered Metal Stent placement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00433771

E7009

ENDO-WALLFLEX-BIL-PALL-001U

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

74 participants in 1 patient group

WallFlex Biliary Fully Covered stent

Experimental group

Description:

Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent

Treatment:

Device: WallFlex™ Biliary Fully Covered Metal Stent placement