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

Study Overview
=================
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) when used per standard of practice.

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.

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

Conditions
-----------------
Biliary Strictures

Intervention / Treatment
-----------------
* Device: WallFlex™ Biliary RX Fully Covered Stent System RMV
* Device: WallFlex™ Biliary RX Partially Covered Stent System
* Device: WallFlex™ Biliary RX Uncovered Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Palliation<br>Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery | Device: WallFlex™ Biliary RX Fully Covered Stent System RMV<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures<br>Device: WallFlex™ Biliary RX Partially Covered Stent System<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms.<br>Device: WallFlex™ Biliary RX Uncovered Stent System<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms.<br>|
| Curative intent surgery<br>Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy | Device: WallFlex™ Biliary RX Partially Covered Stent System<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms.<br>Device: WallFlex™ Biliary RX Uncovered Stent System<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms.<br>|
| Benign biliary strictures<br>Treatment of benign biliary strictures | Device: WallFlex™ Biliary RX Fully Covered Stent System RMV<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures<br>Device: WallFlex™ Biliary RX Partially Covered Stent System<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms.<br>Device: WallFlex™ Biliary RX Uncovered Stent System<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms.<br>|
| Other indication<br>Other indication | Device: WallFlex™ Biliary RX Partially Covered Stent System<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms.<br>Device: WallFlex™ Biliary RX Uncovered Stent System<br>* For use in the palliative treatment of biliary strictures produced by malignant neoplasms.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Indication for stent placement | Distribution of indications for stent placement | 12 Months | 
| Stent types | Distribution of stent types by indication for stent placement | 12 Months | 
| Biliary obstructive symptoms | Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline | 24 Months | 
| Technical success at placement | Technical success at placement defined as ability to deploy the stent in a satisfactory position | 24 Months | 
| 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 | 
| Neoadjuvant therapy | Ability to complete the planned neoadjuvant therapy regimen without interruptions | 24 Months | 
| Stricture resolution | Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal | 24 Months | 
| Time to recurrence of original stricture | Time to recurrence of original stricture | 24 Months | 
| Resolution of the indication for stent placement | Resolution of the indication for stent placement | 24 Months |