<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/NCT03767842</url>
  </required_header>
  <id_info>
    <org_study_id>CH007</org_study_id>
    <nct_id>NCT03767842</nct_id>
  </id_info>
  <brief_title>Volumetric Impedance to Guide Stroke Response</brief_title>
  <acronym>VIGOR</acronym>
  <official_title>Volumetric Impedance to Guide Stroke Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cerebrotech Medical Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cerebrotech Medical Systems, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 18, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2019</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Hemispheric bioimpedance asymmetry sensitivity and specificity</measure>
    <time_frame>At the time of device monitoring - day 0</time_frame>
    <description>Ability of the device to detect bioimpedance asymmetry in patients presenting with symptoms of acute stroke</description>
  </primary_outcome>
  <enrollment type="Anticipated">316</enrollment>
  <condition>Stroke, Acute</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Visor System</intervention_name>
    <description>Subjects are monitored one time with the Visor System.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting for evaluation of acute stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being evaluated as a suspected stroke&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Christopher P Kellner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mt Sinai Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrei V Alexandrov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raul G Nogueira, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University School of Medicine, Grady Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adrian Parker</last_name>
    <phone>978-409-0451</phone>
    <email>aparker@vastrax.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Buffalo Neurosurgery</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adrian Parker</last_name>
      <phone>978-409-0451</phone>
      <email>aparker@vastrax.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Kellner CP, Sauvageau E, Snyder KV, Fargen KM, Arthur AS, Turner RD, Alexandrov AV. The VITAL study and overall pooled analysis with the VIPS non-invasive stroke detection device. J Neurointerv Surg. 2018 Nov;10(11):1079-1084. doi: 10.1136/neurintsurg-2017-013690. Epub 2018 Mar 6.</citation>
    <PMID>29511114</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</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>Stroke</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/NCT03767842
org study id: CH007
nct id: NCT03767842
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Assess the ability of the Visor System to detect hemispheric bioimpedance asymmetry
observational model: Cohort
time perspective: Prospective
measure: Hemispheric bioimpedance asymmetry sensitivity and specificity
time frame: At the time of device monitoring - day 0
description: Ability of the device to detect bioimpedance asymmetry in patients presenting with symptoms of acute stroke
intervention type: Device
intervention name: Visor System
description: Subjects are monitored one time with the Visor System.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Christopher P Kellner, MD
role: Principal Investigator
affiliation: Mt Sinai Health System
last name: Andrei V Alexandrov, MD
role: Principal Investigator
affiliation: University of Tennessee
last name: Raul G Nogueira, MD
role: Principal Investigator
affiliation: Emory University School of Medicine, Grady Memorial Hospital
last name: Adrian Parker
phone: 978-409-0451
email: aparker@vastrax.com
facility: 
status: Recruiting
contact: 
country: United States
citation: Kellner CP, Sauvageau E, Snyder KV, Fargen KM, Arthur AS, Turner RD, Alexandrov AV. The VITAL study and overall pooled analysis with the VIPS non-invasive stroke detection device. J Neurointerv Surg. 2018 Nov;10(11):1079-1084. doi: 10.1136/neurintsurg-2017-013690. Epub 2018 Mar 6.
PMID: 29511114
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No