At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 74 enrolled
Drug / intervention
WallFlex™ Biliary Fully Covered Metal Stent placementdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
In Brief
A Phase 3 clinical trial evaluating WallFlex™ Biliary Fully Covered Metal Stent placement for Cholestasis, Extrahepatic. Completed, enrolled 74 participants across 10 sites.
Detailed Summary
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholestasis, Extrahepatic
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2007
Enrollment StartMar 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedFeb 12, 2007
Enrollment StartMar 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.4 years ago
Interventions
WallFlex™ Biliary Fully Covered Metal Stent placementdevice
Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.