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Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

Cook Group logo

Cook Group

Status

Completed

Conditions

Jaundice, Obstructive
Biliary Tract Neoplasms
Pancreatic Neoplasms

Treatments

Device: 10 mm Nitinol Zilver Stent
Device: 10 mm Stainless Steel Wallstent
Device: 6 mm Nitinol Zilver Stent

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

241 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

241 participants in 3 patient groups

6 mm Zilver
Experimental group
Description:
6 mm Nitinol Zilver Stent
Treatment:
Device: 6 mm Nitinol Zilver Stent
10 mm Zilver
Experimental group
Description:
10 mm Nitinol Zilver Stent
Treatment:
Device: 10 mm Nitinol Zilver Stent
10 mm Wallstent
Active Comparator group
Description:
10 mm Stainless Steel Wallstent
Treatment:
Device: 10 mm Stainless Steel Wallstent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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