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Completed

NCT Number: NCT02261623

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

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.

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Key information

Conditions

Biliary Strictures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peter Lougheed Centre, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

WallFlex™ Biliary RX Fully Covered Stent System RMV

Device

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

Device

For use in the palliative treatment of biliary strictures produced by malignant neoplasms.

WallFlex™ Biliary RX Uncovered Stent System

Device

For use in the palliative treatment of biliary strictures produced by malignant neoplasms.

Primary outcomes

  1. Stent Functionality

    Time frame: 24 Months

    Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell

Secondary outcomes

  1. Serious adverse events

    Time frame: 24 Months

    Occurrence of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable

  2. Indication for stent placement

    Time frame: 12 Months

    Distribution of indications for stent placement

  3. Stent types

    Time frame: 12 Months

    Distribution of stent types by indication for stent placement

  4. Biliary obstructive symptoms

    Time frame: 24 Months

    Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline

  5. Technical success at placement

    Time frame: 24 Months

    Technical success at placement defined as ability to deploy the stent in a satisfactory position

  6. Technical success at removal

    Time frame: 24 Months

    Technical success at removal (as applicable) defined as ability to remove the stent endoscopically without serious adverse device removal related event

  7. Neoadjuvant therapy

    Time frame: 24 Months

    Ability to complete the planned neoadjuvant therapy regimen without interruptions

  8. Stricture resolution

    Time frame: 24 Months

    Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal

  9. Time to recurrence of original stricture

    Time frame: 24 Months

    Time to recurrence of original stricture

  10. Resolution of the indication for stent placement

    Time frame: 24 Months

    Resolution of the indication for stent placement

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 10, 2014
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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