Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
Status
Completed
Conditions
Biliary Strictures
Treatments
Device: WallFlex™ Biliary RX Uncovered Stent System
Device: WallFlex™ Biliary RX Partially Covered Stent System
Device: WallFlex™ Biliary RX Fully Covered Stent System RMV
Details and patient eligibility
About
The purpose of this study is to document stent functionality and practice patterns in Canada pertaining to indications for use and stent type selection for self-expanding biliary metal stents (SEMS) when used per standard of practice.
Full description
This study is designed to provide a report of these features related to the use of WallFlex metal biliary stents used per standard of practice in Canada.
Enrollment
415 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Subject indicated for biliary metal stent placement per local standard of practice
- Age 18 or older
- Willing and able to comply with study procedures and follow-up schedule
- Willing and able to provide written informed consent to participate in study
Exclusion criteria
- Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
- Subjects who the investigator deems at risk for device or procedure related complications per the Directions for Use (DFU)
Trial design
415 participants in 4 patient groups
Palliation
Description:
Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery
Treatment:
Device: WallFlex™ Biliary RX Uncovered Stent System
Device: WallFlex™ Biliary RX Partially Covered Stent System
Device: WallFlex™ Biliary RX Fully Covered Stent System RMV
Curative intent surgery
Description:
Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy
Treatment:
Device: WallFlex™ Biliary RX Uncovered Stent System
Device: WallFlex™ Biliary RX Partially Covered Stent System
Benign biliary strictures
Description:
Treatment of benign biliary strictures
Treatment:
Device: WallFlex™ Biliary RX Uncovered Stent System
Device: WallFlex™ Biliary RX Partially Covered Stent System
Device: WallFlex™ Biliary RX Fully Covered Stent System RMV
Other indication
Description:
Other indication
Treatment:
Device: WallFlex™ Biliary RX Uncovered Stent System
Device: WallFlex™ Biliary RX Partially Covered Stent System
Trial contacts and locations
12
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Data sourced from clinicaltrials.gov
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