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2003-09
2006-12
2006-12
241
NCT00196105
Cook Group Incorporated
Cook Group Incorporated
INTERVENTIONAL
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2005-09-12 | 2009-09-25 | 2011-09-28 |
2005-09-12 | 2010-01-11 | 2011-10-03 |
2005-09-20 | 2010-01-12 | 2011-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Patency | 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) | 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 | up to 32 months | |
| Number of Deaths | up to 32 months | |
| Time to Death | Overall Survival | up to 32 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
21 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
