Malignant Obstruction ZILVER Against Routine Therapy (MOZART I) - Full Text View

Sponsored by:	Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00196105

Purpose

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.

Condition	Intervention
Biliary Tract Neoplasms Pancreatic Neoplasms Jaundice, Obstructive	Device: Zilver biliary endoprostheses

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction

Further study details as provided by Cook:

Primary Outcome Measures:

Stent occlusion
Death

Secondary Outcome Measures:

Reinterventions
Complications
Technical placement difficulties
Physician-graded ease of placement

Study Start Date:	September 2003
Estimated Study Completion Date:	January 2008

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Unresectable malignancy of the extrahepatic bile duct

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196105

Locations

United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102

Sponsors and Collaborators

Cook

Investigators

Principal Investigator:

Douglas Howell, M.D.

Maine Medical Center

More Information

Study ID Numbers:	03-MOZ
Study First Received:	September 12, 2005
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00196105
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Canada: Health Canada

Keywords provided by Cook:

Stents
Stent-graft
Minimally invasive
Biliary Tract Cancer
Pancreatic Cancer

Jaundice
Biliary Tract Neoplasms
Pancreatic Neoplasms
Jaundice, Obstructive
Zilver

Study placed in the following topic categories:

Biliary Tract Neoplasms
Digestive System Neoplasms
Pancreatic Neoplasms
Biliary tract cancer
Endocrine System Diseases
Jaundice, Obstructive
Signs and Symptoms
Digestive System Diseases

Biliary Tract Diseases
Hyperbilirubinemia
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Jaundice
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Skin Manifestations
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009