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

Completed · Phase 3

Conditions studied: Cholestasis, Extrahepatic

In brief

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.

Key facts

Study ID

NCT00433771

Run by

Boston Scientific Corporation

People needed

74

Starts

2007-03-01

Expected to finish

2008-05-01

Last updated by the study team

2010-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• California Pacific Medical Center — San Francisco, California, United States
• Univ. of Colorado Health Sciences — Aurora, Colorado, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Duke University Med Center — Durham, North Carolina, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Univ. of VA Medical Center — Charlottesville, Virginia, United States
• Virginia Mason Seattle Main Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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