WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

NACompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

September 18, 2012

Primary Completion Date

September 21, 2020

Study Completion Date

September 21, 2020

Conditions
Biliary Stricture
Interventions
DEVICE

WallFlex™ Biliary RX Fully Covered Stent System RMV

"Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell. (RMV in intervention name indicates removable)"

DEVICE

Commercially available Plastic Stent Per Investigator preference

Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.

Trial Locations (14)

1070

Erasme Hospital, Brussels

2042

Royal Prince Alfred Medical Center, Newtown

2145

Westmead Hospital, Westmead

3000

UZ Gasthuisberg, Leuven

3015

Erasmus Medical Center, Rotterdam

37134

Azienda Ospedaliera Universitaria Integrata di Verona, Verona

69437

Hopital Edouard Herriot, Lyon

A-1090

Allgemeines Krankenhaus AKH, Vienna

H2X 3J4

CHUM - Hopital Saint-Luc, Montreal

D-40217

Evangelisches Krankenhaus Dusseldorf, Düsseldorf

Unknown

Prince of Wales Hospital, Shatin

500 082

Asian Institute of Gastroenterology, Hyderabad

00168

Policlinico Universitario Agostino Gemelli, Rome

S-14186

Karolinska Universitets Sjukhuset, Stockholm

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY