NCT00713427

Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Strictures Caused by Malignant Neoplasms

Interventions

Type	Name	Description
DEVICE	WallFlex™ Biliary Partially-Covered Stent	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.

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-07-11
• Last updated: 2021-07-30
• Results posted: 2021-06-04

Locations

6 sites across 6 countries: Belgium, France, Germany, India, Italy, Netherlands