Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

Biliary Strictures Clinical Trial

Official title:

Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261623
• Other study ID #: 90921899
• Status: Completed
• Start date: March 19, 2015
• Est. completion date: March 31, 2016

Study information

• Verified date: January 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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) when used per standard of practice.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Biliary Strictures
• Constriction, Pathologic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hopital Charles Le Moyne	Greenfield Park	Quebec
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia
Canada	CHUM - Hopital Saint-Luc	Montreal	Quebec
Canada	Oakville-Trafalgar Memorial Hospital	Oakville	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHUS Hotel Dieu	Sherbrooke	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Providence Health - St. Paul's Hospital	Vancouver	British Columbia
Canada	Victoria General Hospital	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent Functionality	Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell	24 Months
Secondary	Serious adverse events	Occurrence of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable	24 Months
Secondary	Indication for stent placement	Distribution of indications for stent placement	12 Months
Secondary	Stent types	Distribution of stent types by indication for stent placement	12 Months
Secondary	Biliary obstructive symptoms	Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline	24 Months
Secondary	Technical success at placement	Technical success at placement defined as ability to deploy the stent in a satisfactory position	24 Months
Secondary	Technical success at removal	Technical success at removal (as applicable) defined as ability to remove the stent endoscopically without serious adverse device removal related event	24 Months
Secondary	Neoadjuvant therapy	Ability to complete the planned neoadjuvant therapy regimen without interruptions	24 Months
Secondary	Stricture resolution	Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal	24 Months
Secondary	Time to recurrence of original stricture	Time to recurrence of original stricture	24 Months
Secondary	Resolution of the indication for stent placement	Resolution of the indication for stent placement	24 Months