NCT00196105

Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Neoplasms
• Pancreatic Neoplasms
• Jaundice, Obstructive

Interventions

Type	Name	Description
DEVICE	6 mm Nitinol Zilver Stent
DEVICE	10 mm Nitinol Zilver Stent
DEVICE	10 mm Stainless Steel Wallstent

Timeline

• Start date: 2003-09-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-20
• Last updated: 2011-10-03
• Results posted: 2010-01-12

Locations

1 site across 1 country: United States