CompletedNot Applicable

Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

United States241 participantsStarted 2003-09

Plain-language summary

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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patency

Timeframe: up to 32 months

Closure or Blockage of the Stent (Occlusion)

Timeframe: up to 32 months

Number of Days to Occlusion

Timeframe: up to 32 months

Number of Deaths

Timeframe: up to 32 months

Time to Death

Timeframe: up to 32 months

Trial details

NCT IDNCT00196105

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-12

Results submitted2009-09-25

View on ClinicalTrials.gov More Biliary Tract Neoplasms trials