Status:
COMPLETED
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
Lead Sponsor:
Cook Group Incorporated
Conditions:
Biliary Tract Neoplasms
Pancreatic Neoplasms
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of...
Detailed Description
This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid s...
Eligibility Criteria
Inclusion
- Unresectable malignancy of the extrahepatic bile duct
Exclusion
- Age below 21 years
- Pregnancy
- Active alcohol or drug abuse
- Simultaneously participating in another investigational drug or device study.
- Allergy to stainless steel or nitinol
- Active cholangitis
- Brachytherapy
- Unable or unwilling to comply with follow up
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00196105
Start Date
September 1 2003
End Date
December 1 2006
Last Update
October 3 2011
Active Locations (1)
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1
Maine Medical Center
Portland, Maine, United States, 04102