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

January 3, 2020 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
415

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Peter Lougheed Centre
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada, T6G 2P4
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Providence Health - St. Paul's Hospital
      • Victoria, British Columbia, Canada, V8R 1J8
        • Victoria General Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Center
    • Ontario
      • Oakville, Ontario, Canada, L6J 3L7
        • Oakville-Trafalgar Memorial Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles Le Moyne
      • Montreal, Quebec, Canada, H2X 3J4
        • CHUM - Hopital Saint-Luc
      • Sherbrooke, Quebec, Canada, J1K 2R1
        • CHUS Hotel Dieu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been diagnosed with a blockage of the bile duct which may be caused by a benign or malignant biliary stricture.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Palliation
Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery
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
Device: WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Device: 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
Device: WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Device: 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
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
Device: WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Device: WallFlex™ Biliary RX Uncovered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Other indication
Device: WallFlex™ Biliary RX Partially Covered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Device: WallFlex™ Biliary RX Uncovered Stent System
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 Months
Indication for stent placement
Time Frame: 12 Months
Distribution of indications for stent placement
12 Months
Stent types
Time Frame: 12 Months
Distribution of stent types by indication for stent placement
12 Months
Biliary obstructive symptoms
Time Frame: 24 Months
Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline
24 Months
Technical success at placement
Time Frame: 24 Months
Technical success at placement defined as ability to deploy the stent in a satisfactory position
24 Months
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
24 Months
Neoadjuvant therapy
Time Frame: 24 Months
Ability to complete the planned neoadjuvant therapy regimen without interruptions
24 Months
Stricture resolution
Time Frame: 24 Months
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 Frame: 24 Months
Time to recurrence of original stricture
24 Months
Resolution of the indication for stent placement
Time Frame: 24 Months
Resolution of the indication for stent placement
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gurpal Sandha, MD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90921899

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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