Status:
COMPLETED
Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Biliary Strictures
Eligibility:
All Genders
18+ years
Brief Summary
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) w...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 19 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2016
Estimated Enrollment :
415 Patients enrolled
Trial Details
Trial ID
NCT02261623
Start Date
March 19 2015
End Date
March 31 2016
Last Update
January 6 2020
Active Locations (12)
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1
Peter Lougheed Centre
Calgary, Alberta, Canada, T2N 2T9
2
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
3
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2P4
4
Providence Health - St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 2K5