Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

September 28, 2011 updated by: Cook Group Incorporated

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

241

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6 mm Zilver
6 mm Nitinol Zilver Stent
Device: 6 mm Nitinol Zilver Stent
Experimental: 10 mm Zilver
10 mm Nitinol Zilver Stent
Device: 10 mm Nitinol Zilver Stent
Active Comparator: 10 mm Wallstent
10 mm Stainless Steel Wallstent
Device: 10 mm Stainless Steel Wallstent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency
Time Frame: up to 32 months
Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).
up to 32 months
Closure or Blockage of the Stent (Occlusion)
Time Frame: up to 32 months
Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.
up to 32 months
Number of Days to Occlusion
Time Frame: up to 32 months
up to 32 months
Number of Deaths
Time Frame: up to 32 months
up to 32 months
Time to Death
Time Frame: up to 32 months
Overall Survival
up to 32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: Douglas Howell, M.D., MaineHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 3, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-MOZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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