CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 187 enrolled
Drug / intervention
WallFlex Biliary RX Fully Covered Stent Systemdevice
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/NCT01014390
NCT01014390Phase 3Completed
CompareCT.gov

A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures

Boston Scientific Corporation·interventional·Posted Nov 17, 2009·Updated Feb 19, 2020

In Brief

A Phase 3 clinical trial evaluating WallFlex Biliary RX Fully Covered Stent System for Biliary Stricture. Completed, enrolled 187 participants across 13 sites in 11 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Stricture
CountriesAustralia, Austria, Belgium, Canada, Chile, France, Germany, India, Italy, Netherlands, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2009
Enrollment StartDec 1, 2009
Primary CompletionNov 1, 2012
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 16.6 years ago

Interventions

WallFlex Biliary RX Fully Covered Stent Systemdevice

Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.