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Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

NCT ID: NCT00196105

Last Updated: 2011-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-12-31

Brief Summary

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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

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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

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Biliary Tract Neoplasms Pancreatic Neoplasms Jaundice, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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6 mm Zilver

6 mm Nitinol Zilver Stent

Group Type EXPERIMENTAL

6 mm Nitinol Zilver Stent

Intervention Type DEVICE

10 mm Zilver

10 mm Nitinol Zilver Stent

Group Type EXPERIMENTAL

10 mm Nitinol Zilver Stent

Intervention Type DEVICE

10 mm Wallstent

10 mm Stainless Steel Wallstent

Group Type ACTIVE_COMPARATOR

10 mm Stainless Steel Wallstent

Intervention Type DEVICE

Interventions

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6 mm Nitinol Zilver Stent

Intervention Type DEVICE

10 mm Nitinol Zilver Stent

Intervention Type DEVICE

10 mm Stainless Steel Wallstent

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas Howell, M.D.

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Locations

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Maine Medical Center

Portland, Maine, United States

Site Status

Countries

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United States

References

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Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc. 2009 Sep;70(3):445-53. doi: 10.1016/j.gie.2008.11.018. Epub 2009 May 30.

Reference Type RESULT
PMID: 19482279 (View on PubMed)

Other Identifiers

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03-MOZ

Identifier Type: -

Identifier Source: org_study_id