Status:
COMPLETED
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Biliary Strictures Caused by Malignant Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 functionali...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00713427
Start Date
July 1 2007
End Date
May 1 2008
Last Update
July 30 2021
Active Locations (6)
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1
ULB Erasme Hospital
Brussels, Belgium, 1070
2
Hopital Edouard Herriot
Lyon, Cedex 3, France, 69437
3
EVK Krankenhaus der Universitat Dusseldorf
Düsseldorf, Germany, D-40217
4
Asian Institute of Gastroenterology
Hyderabaad, India, 500082