CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 241 enrolled
Drug / intervention
6 mm Nitinol Zilver Stent +2 moredevice
Likely dose
6 mm or 10 mm Nitinol Zilver Expandable Stent, or 10 mm Stainless Steel WallstentAI-extracted
Key inclusion· 1
  • ✓Unresectable malignancy of the extrahepatic bile duct
Key exclusion· 6
  • ✕Age below 21 years
  • ✕Pregnancy
  • ✕Active alcohol or drug abuse
  • ✕Allergy to stainless steel or nitinol

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00196105
NCT00196105N/ACompleted
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Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction

Cook Group Incorporated·interventional·Posted Sep 20, 2005·Updated Oct 3, 2011

In Brief

A clinical study evaluating 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, and 1 other intervention for Biliary Tract Neoplasms and 2 related conditions. Completed, enrolled 241 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartSep 1, 2003
Primary CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

6 mm Nitinol Zilver Stentdevice

10 mm Nitinol Zilver Stentdevice

10 mm Stainless Steel Wallstentdevice