<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/NCT03775694</url>
  </required_header>
  <id_info>
    <org_study_id>MDT17084</org_study_id>
    <nct_id>NCT03775694</nct_id>
  </id_info>
  <brief_title>Diffusion MRI-1 Imaging Database</brief_title>
  <acronym>dMRI-1</acronym>
  <official_title>Diffusion MRI-1 Imaging Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Spinal and Biologics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Spinal and Biologics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the dMRI-1 data collection study is to establish a database of clinical images&#xD;
      and limited medical history information from patients that have previously received a dMRI&#xD;
      scan. All data collected will be de-identified. No safety or effectiveness assessments will&#xD;
      be completed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2019</start_date>
  <completion_date type="Actual">April 29, 2022</completion_date>
  <primary_completion_date type="Actual">April 29, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Image assessment</measure>
    <time_frame>Procedure</time_frame>
  </primary_outcome>
  <enrollment type="Actual">299</enrollment>
  <condition>Epilepsy</condition>
  <condition>Tumor</condition>
  <condition>Healthy</condition>
  <condition>Other</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>dMRI Scan</intervention_name>
    <description>Data will be collected from cases where dMRI scans were obtained as part of the subject's previous treatment.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have previously received a dMRI scan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is either ≥ 18 years and has previously received an acceptable dMRI scan(s)&#xD;
             with at least 30 unique gradient directions or &lt; 18 years who has previously received&#xD;
             an acceptable dMRI scan of any number of unique gradient directions and who is allowed&#xD;
             to participate in this type of research project (e.g., IRB/EC approval with waiver of&#xD;
             consent) per IRB/EC&#xD;
&#xD;
          2. Acceptable dMRI scan was completed prior to site activation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</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>Epilepsy</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/NCT03775694
org study id: MDT17084
nct id: NCT03775694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of the dMRI-1 data collection study is to establish a database of clinical images
      and limited medical history information from patients that have previously received a dMRI
      scan. All data collected will be de-identified. No safety or effectiveness assessments will
      be completed.
observational model: Case-Only
time perspective: Retrospective
measure: Image assessment
time frame: Procedure
intervention type: Device
intervention name: dMRI Scan
description: Data will be collected from cases where dMRI scans were obtained as part of the subject's previous treatment.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Epilepsy