Biliary StricturesNCT02261623
Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
An observational study of Biliary Strictures, run by Boston Scientific Corporation at 12 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Strictures
- What is being tested?
- WallFlex™ Biliary RX Fully Covered Stent System RMV, WallFlex™ Biliary RX Partially Covered Stent System and WallFlex™ Biliary RX Uncovered Stent System
- Type of treatment
- Medical device
- How many people
- 415 participants
- Where
- 12 sitesCanada
- Study dates
- 19 Mar 2015to 31 Mar 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Peter Lougheed Centre
Calgary, Alberta, T2N 2T9
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, T6G 2P4
Hopital Charles Le Moyne
Greenfield Park, Quebec, J4V 2H1
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 2Y9
CHUM - Hopital Saint-Luc
Montreal, Quebec, H2X 3J4
Oakville-Trafalgar Memorial Hospital
Oakville, Ontario, L6J 3L7
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
CHUS Hotel Dieu
Sherbrooke, Quebec, J1K 2R1
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Providence Health - St. Paul's Hospital
Vancouver, British Columbia, V6Z 2K5
Victoria General Hospital
Victoria, British Columbia, V8R 1J8
About this study
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.
Read the 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.
- Conditions
- Biliary Strictures
- Being tested
- WallFlex™ Biliary RX Fully Covered Stent System RMV, WallFlex™ Biliary RX Partially Covered Stent System, WallFlex™ Biliary RX Uncovered Stent System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex™ Biliary RX Fully Covered Stent System RMVDevice
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 SystemDevice
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
WallFlex™ Biliary RX Uncovered Stent SystemDevice
For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
| Study group | Role | What they receive |
|---|---|---|
| Palliation | Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery Receives: Device: WallFlex™ Biliary RX Fully Covered Stent System RMV; Device: WallFlex™ Biliary RX Partially Covered Stent System; Device: WallFlex™ Biliary RX Uncovered Stent System | |
| Curative intent surgery | Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy Receives: Device: WallFlex™ Biliary RX Partially Covered Stent System; Device: WallFlex™ Biliary RX Uncovered Stent System | |
| Benign biliary strictures | Treatment of benign biliary strictures Receives: Device: WallFlex™ Biliary RX Fully Covered Stent System RMV; Device: WallFlex™ Biliary RX Partially Covered Stent System; Device: WallFlex™ Biliary RX Uncovered Stent System | |
| Other indication | Other indication Receives: Device: WallFlex™ Biliary RX Partially Covered Stent System; Device: WallFlex™ Biliary RX Uncovered Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Functionality
Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell
Measured: 24 Months
Secondary outcomes (10)
Serious adverse events
Occurrence of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable
Measured: 24 Months
Indication for stent placement
Distribution of indications for stent placement
Measured: 12 Months
Stent types
Distribution of stent types by indication for stent placement
Measured: 12 Months
Biliary obstructive symptoms
Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline
Measured: 24 Months
Technical success at placement
Technical success at placement defined as ability to deploy the stent in a satisfactory position
Measured: 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
Measured: 24 Months
Neoadjuvant therapy
Ability to complete the planned neoadjuvant therapy regimen without interruptions
Measured: 24 Months
Stricture resolution
Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal
Measured: 24 Months
Time to recurrence of original stricture
Time to recurrence of original stricture
Measured: 24 Months
Resolution of the indication for stent placement
Resolution of the indication for stent placement
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start19 Mar 2015
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StricturesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 415 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gurpal Sandha, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261623
- Sponsor's protocol ID
- 90921899
- Status last verified
- Jan 2020
- First submitted
- 7 Oct 2014
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
- ClinicalTrials.gov ID
- NCT02261623
- Acronym / sponsor ID
- 90921899
- Conditions
- Biliary Strictures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Palliation | – | Device: WallFlex™ Biliary RX Fully Covered Stent System RMV, Device: WallFlex™ Biliary RX Partially Covered Stent System, Device: WallFlex™ Biliary RX Uncovered Stent SystemPalliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery |
| Curative intent surgery | – | Device: WallFlex™ Biliary RX Partially Covered Stent System, Device: WallFlex™ Biliary RX Uncovered Stent SystemPalliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy |
| Benign biliary strictures | – | Device: WallFlex™ Biliary RX Fully Covered Stent System RMV, Device: WallFlex™ Biliary RX Partially Covered Stent System, Device: WallFlex™ Biliary RX Uncovered Stent SystemTreatment of benign biliary strictures |
| Other indication | – | Device: WallFlex™ Biliary RX Partially Covered Stent System, Device: WallFlex™ Biliary RX Uncovered Stent SystemOther indication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WallFlex™ Biliary RX Fully Covered Stent System RMVFor use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures | Device | Benign biliary strictures, Palliation |
| WallFlex™ Biliary RX Partially Covered Stent SystemFor use in the palliative treatment of biliary strictures produced by malignant neoplasms. | Device | Benign biliary strictures, Curative intent surgery, Other indication, Palliation |
| WallFlex™ Biliary RX Uncovered Stent SystemFor use in the palliative treatment of biliary strictures produced by malignant neoplasms. | Device | Benign biliary strictures, Curative intent surgery, Other indication, Palliation |
Primary outcome
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
10 secondary outcomes
Serious adverse events
Time frame: 24 Months
Indication for stent placement
Time frame: 12 Months
Stent types
Time frame: 12 Months
Biliary obstructive symptoms
Time frame: 24 Months
Technical success at placement
Time frame: 24 Months
Technical success at removal
Time frame: 24 Months
Neoadjuvant therapy
Time frame: 24 Months
Stricture resolution
Time frame: 24 Months
Time to recurrence of original stricture
Time frame: 24 Months
Resolution of the indication for stent placement
Time frame: 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurpal Sandha, MD principal investigator
University of Alberta
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Strictures, run by Boston Scientific Corporation at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent Functionality (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.