<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261623</url>
  </required_header>
  <id_info>
    <org_study_id>90921899</org_study_id>
    <nct_id>NCT02261623</nct_id>
  </id_info>
  <brief_title>Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry</brief_title>
  <official_title>Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to document stent functionality and practice patterns in Canada&#xD;
      pertaining to indications for use and stent type selection for self-expanding biliary metal&#xD;
      stents (SEMS) when used per standard of practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to provide a report of these features related to the use of WallFlex&#xD;
      metal biliary stents used per standard of practice in Canada.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2015</start_date>
  <completion_date type="Actual">March 31, 2016</completion_date>
  <primary_completion_date type="Actual">March 31, 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Stent Functionality</measure>
    <time_frame>24 Months</time_frame>
    <description>Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>24 Months</time_frame>
    <description>Occurrence of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indication for stent placement</measure>
    <time_frame>12 Months</time_frame>
    <description>Distribution of indications for stent placement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent types</measure>
    <time_frame>12 Months</time_frame>
    <description>Distribution of stent types by indication for stent placement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biliary obstructive symptoms</measure>
    <time_frame>24 Months</time_frame>
    <description>Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success at placement</measure>
    <time_frame>24 Months</time_frame>
    <description>Technical success at placement defined as ability to deploy the stent in a satisfactory position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success at removal</measure>
    <time_frame>24 Months</time_frame>
    <description>Technical success at removal (as applicable) defined as ability to remove the stent endoscopically without serious adverse device removal related event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neoadjuvant therapy</measure>
    <time_frame>24 Months</time_frame>
    <description>Ability to complete the planned neoadjuvant therapy regimen without interruptions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stricture resolution</measure>
    <time_frame>24 Months</time_frame>
    <description>Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence of original stricture</measure>
    <time_frame>24 Months</time_frame>
    <description>Time to recurrence of original stricture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resolution of the indication for stent placement</measure>
    <time_frame>24 Months</time_frame>
    <description>Resolution of the indication for stent placement</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">415</enrollment>
  <condition>Biliary Strictures</condition>
  <arm_group>
    <arm_group_label>Palliation</arm_group_label>
    <description>Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Curative intent surgery</arm_group_label>
    <description>Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benign biliary strictures</arm_group_label>
    <description>Treatment of benign biliary strictures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other indication</arm_group_label>
    <description>Other indication</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WallFlex™ Biliary RX Fully Covered Stent System RMV</intervention_name>
    <description>For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures</description>
    <arm_group_label>Benign biliary strictures</arm_group_label>
    <arm_group_label>Palliation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WallFlex™ Biliary RX Partially Covered Stent System</intervention_name>
    <description>For use in the palliative treatment of biliary strictures produced by malignant neoplasms.</description>
    <arm_group_label>Benign biliary strictures</arm_group_label>
    <arm_group_label>Curative intent surgery</arm_group_label>
    <arm_group_label>Other indication</arm_group_label>
    <arm_group_label>Palliation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WallFlex™ Biliary RX Uncovered Stent System</intervention_name>
    <description>For use in the palliative treatment of biliary strictures produced by malignant neoplasms.</description>
    <arm_group_label>Benign biliary strictures</arm_group_label>
    <arm_group_label>Curative intent surgery</arm_group_label>
    <arm_group_label>Other indication</arm_group_label>
    <arm_group_label>Palliation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have been diagnosed with a blockage of the bile duct which may be caused by a&#xD;
        benign or malignant biliary stricture.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject indicated for biliary metal stent placement per local standard of practice&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Willing and able to comply with study procedures and follow-up schedule&#xD;
&#xD;
          -  Willing and able to provide written informed consent to participate in study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are currently enrolled in another investigational study that would&#xD;
             directly interfere with the current study, without prior written approval from the&#xD;
             sponsor&#xD;
&#xD;
          -  Subjects who the investigator deems at risk for device or procedure related&#xD;
             complications per the Directions for Use (DFU)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gurpal Sandha, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peter Lougheed Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2P4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Health - St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria General Hospital</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R 1J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Center</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oakville-Trafalgar Memorial Hospital</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6J 3L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Charles Le Moyne</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUM - Hopital Saint-Luc</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 3J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUS Hotel Dieu</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1K 2R1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>January 3, 2020</last_update_submitted>
  <last_update_submitted_qc>January 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261623
org study id: 90921899
nct id: NCT02261623
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Stent Functionality
time frame: 24 Months
description: Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell
measure: Serious adverse events
time frame: 24 Months
description: Occurrence of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable
measure: Indication for stent placement
time frame: 12 Months
description: Distribution of indications for stent placement
measure: Stent types
time frame: 12 Months
description: Distribution of stent types by indication for stent placement
measure: Biliary obstructive symptoms
time frame: 24 Months
description: Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline
measure: Technical success at placement
time frame: 24 Months
description: Technical success at placement defined as ability to deploy the stent in a satisfactory position
measure: Technical success at removal
time frame: 24 Months
description: Technical success at removal (as applicable) defined as ability to remove the stent endoscopically without serious adverse device removal related event
measure: Neoadjuvant therapy
time frame: 24 Months
description: Ability to complete the planned neoadjuvant therapy regimen without interruptions
measure: Stricture resolution
time frame: 24 Months
description: Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal
measure: Time to recurrence of original stricture
time frame: 24 Months
description: Time to recurrence of original stricture
measure: Resolution of the indication for stent placement
time frame: 24 Months
description: Resolution of the indication for stent placement
arm group label: Palliation
description: Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery
arm group label: Curative intent surgery
description: Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy
arm group label: Benign biliary strictures
description: Treatment of benign biliary strictures
arm group label: Other indication
description: Other indication
intervention type: Device
intervention name: WallFlex™ Biliary RX Fully Covered Stent System RMV
description: For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures
arm group label: Benign biliary strictures
arm group label: Palliation
intervention type: Device
intervention name: WallFlex™ Biliary RX Partially Covered Stent System
description: For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
arm group label: Benign biliary strictures
arm group label: Curative intent surgery
arm group label: Other indication
arm group label: Palliation
intervention type: Device
intervention name: WallFlex™ Biliary RX Uncovered Stent System
description: For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
arm group label: Benign biliary strictures
arm group label: Curative intent surgery
arm group label: Other indication
arm group label: Palliation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gurpal Sandha, MD
role: Principal Investigator
affiliation: University of Alberta
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Constriction, Pathologic