NCT01014390

WallFlex Biliary Fully Covered (FC) Benign Stricture Study

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Stricture

Interventions

Type	Name	Description
DEVICE	WallFlex Biliary RX Fully Covered Stent System	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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-11-01
• Completion: 2017-11-01
• First posted: 2009-11-17
• Last updated: 2020-02-19
• Results posted: 2020-02-19

Locations

13 sites across 11 countries: Australia, Austria, Belgium, Canada, Chile, France, Germany, India, Italy, Netherlands, Spain