Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
NCT ID: NCT02261623
Last Updated: 2020-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
415 participants
OBSERVATIONAL
2015-03-19
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Palliation
Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery
WallFlex™ Biliary RX Fully Covered Stent System RMV
For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures
WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
WallFlex™ Biliary RX Uncovered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Curative intent surgery
Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy
WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
WallFlex™ Biliary RX Uncovered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Benign biliary strictures
Treatment of benign biliary strictures
WallFlex™ Biliary RX Fully Covered Stent System RMV
For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures
WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
WallFlex™ Biliary RX Uncovered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Other indication
Other indication
WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
WallFlex™ Biliary RX Uncovered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Interventions
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WallFlex™ Biliary RX Fully Covered Stent System RMV
For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures
WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
WallFlex™ Biliary RX Uncovered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Eligibility Criteria
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Inclusion Criteria
* 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 the investigator deems at risk for device or procedure related complications per the Directions for Use (DFU)
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gurpal Sandha, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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Peter Lougheed Centre
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Providence Health - St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria General Hospital
Victoria, British Columbia, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Oakville-Trafalgar Memorial Hospital
Oakville, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Hopital Charles Le Moyne
Greenfield Park, Quebec, Canada
CHUM - Hopital Saint-Luc
Montreal, Quebec, Canada
CHUS Hotel Dieu
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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90921899
Identifier Type: -
Identifier Source: org_study_id
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