<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/NCT03021720</url>
  </required_header>
  <id_info>
    <org_study_id>16-0227-A</org_study_id>
    <nct_id>NCT03021720</nct_id>
  </id_info>
  <brief_title>Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial</brief_title>
  <acronym>SPARQLE</acronym>
  <official_title>Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Sinai Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of&#xD;
      life with femoral versus radial arterial access&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus&#xD;
      radial arterial access for uterine fibroid embolization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">February 2020</completion_date>
  <primary_completion_date type="Actual">February 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>From date of procedure to one month after procedure</time_frame>
    <description>Based on visual analog scale (min 0, max 10; higher score indicates better outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure related complication rate</measure>
    <time_frame>Up to one month after procedure</time_frame>
    <description>Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>Duration of intra-procedural time</time_frame>
    <description>Procedure time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy Time</measure>
    <time_frame>Duration of intra-procedural fluoroscopy</time_frame>
    <description>Fluoroscopy time used during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure equipment cost</measure>
    <time_frame>Procedure</time_frame>
    <description>Cost of disposable equipment used for the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>1 month post procedure</time_frame>
    <description>Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Uterine Fibroid</condition>
  <arm_group>
    <arm_group_label>Femoral arterial access</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Femoral arterial puncture for the uterine fibroid embolization procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radial arterial access</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radial arterial puncture for the uterine fibroid embolization procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arterial access</intervention_name>
    <description>Location of arterial puncture</description>
    <arm_group_label>Femoral arterial access</arm_group_label>
    <arm_group_label>Radial arterial access</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meeting standard eligibility criteria for uterine fibroid embolization&#xD;
&#xD;
          -  Satisfactory ulnopalmar arch patency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Unable or unwilling to complete the study questionnaires&#xD;
&#xD;
          -  Failed Barbeau test&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Kachura</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Hospital, University Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mount Sinai Hospital, Canada</investigator_affiliation>
    <investigator_full_name>John Kachura</investigator_full_name>
    <investigator_title>Interventional Radiologist; Associate Professor of Medical Imaging</investigator_title>
  </responsible_party>
  <keyword>Uterine fibroid embolization</keyword>
  <keyword>Uterine artery embolization</keyword>
  <keyword>Arterial access</keyword>
  <keyword>Radial access</keyword>
  <keyword>Interventional radiology</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Patient Satisfaction</keyword>
  <keyword>Patient centered care</keyword>
  <keyword>Uterine fibroid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03021720
org study id: 16-0227-A
nct id: NCT03021720
lead sponsor: 
has dmc: No
Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of
      life with femoral versus radial arterial access
1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus
      radial arterial access for uterine fibroid embolization
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Patient satisfaction
time frame: From date of procedure to one month after procedure
description: Based on visual analog scale (min 0, max 10; higher score indicates better outcome)
measure: Procedure related complication rate
time frame: Up to one month after procedure
description: Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline
measure: Procedure time
time frame: Duration of intra-procedural time
description: Procedure time
measure: Fluoroscopy Time
time frame: Duration of intra-procedural fluoroscopy
description: Fluoroscopy time used during the procedure
measure: Procedure equipment cost
time frame: Procedure
description: Cost of disposable equipment used for the procedure
measure: Health related quality of life
time frame: 1 month post procedure
description: Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)
arm group label: Femoral arterial access
arm group type: Active Comparator
description: Femoral arterial puncture for the uterine fibroid embolization procedure
arm group label: Radial arterial access
arm group type: Experimental
description: Radial arterial puncture for the uterine fibroid embolization procedure
intervention type: Procedure
intervention name: Arterial access
description: Location of arterial puncture
arm group label: Femoral arterial access
arm group label: Radial arterial access
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Kachura
role: Principal Investigator
affiliation: Mount Sinai Hospital, University Health Network
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Mount Sinai Hospital, Canada
investigator full name: John Kachura
investigator title: Interventional Radiologist; Associate Professor of Medical Imaging
mesh term: Leiomyoma
mesh term: Myofibroma
sharing ipd: No