Status:
COMPLETED
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Cholestasis, Extrahepatic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00433771
Start Date
March 1 2007
End Date
May 1 2008
Last Update
June 29 2010
Active Locations (10)
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1
California Pacific Medical Center
San Francisco, California, United States, 94115
2
Univ. of Colorado Health Sciences
Aurora, Colorado, United States, 80010
3
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
4
Mayo Clinic
Rochester, Minnesota, United States, 55905