Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196105
Status:
COMPLETED
Last Update Posted:
2011-10-03
First Post:
2005-09-12
Brief Title:
Malignant Obstruction ZILVER Against Routine Therapy MOZART I
Sponsor:
Cook Group Incorporated
Organization:
Cook Group Incorporated
Study Overview
Official Title:
Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 malignant obstructive jaundice
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 some potential complications and last longer than the conventional stents The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None