NCT01014390 - WallFlex Biliary Fully Covered (FC) Benign Stricture Study | Biotech Hunter

Enrollment

187

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2017

Conditions

Biliary Stricture

Interventions

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.

Trial Locations (13)

2145

Westmead Hospital, Westmead

Unknown

Medical University of Vienna, Vienna

ULB Erasme Hospital, Brussels

St. Michael's Hospital, Toronto

MUHC - McGill University, Montreal

Clinica Alemana de Santiago, Santiago

Hopital Edouard Herriot, Lyon

Evangelischen Krankenhaus, Düsseldorf

Asian Institute of Gastroenterology, Hyderabad

Erasmus Medical Center, Rotterdam

Hospital Universitari Doctor Josep Trueta, Girona

H2X 3J4

Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital, Montreal

00168

Università Cattolica del Sacro Cuore Policlinico A. Gemelli, Rome