CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
WallFlex™ Biliary Partially-Covered Stentdevice
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.

Search/NCT00713427
NCT00713427N/ACompleted
CompareCT.gov

A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Boston Scientific Corporation·interventional·Posted Jul 11, 2008·Updated Jul 30, 2021

In Brief

A clinical study evaluating WallFlex™ Biliary Partially-Covered Stent for Biliary Strictures Caused by Malignant Neoplasms. Completed, enrolled 70 participants across 6 sites in 6 countries.

Detailed Summary

This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Strictures Caused by Malignant Neoplasms
CountriesBelgium, France, Germany, India, Italy, Netherlands
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2008
Enrollment StartJul 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.0 years ago

Interventions

WallFlex™ Biliary Partially-Covered Stentdevice

Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.