<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/NCT03038087</url>
  </required_header>
  <id_info>
    <org_study_id>SENSE-001</org_study_id>
    <nct_id>NCT03038087</nct_id>
  </id_info>
  <brief_title>A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage</brief_title>
  <official_title>An Early Feasibility Study to Evaluate the User Interfaces and Sensitivity of the SENSE Device in Patients With Intracranial Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sense Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sense Diagnostics, LLC</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find out whether a device for monitoring bleeding in&#xD;
      patients with acute hemorrhagic stroke will show similar findings as CT scans performed to&#xD;
      evaluate the stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective, observational, single site, first-in-man study of the SENSE&#xD;
      device in up to 10 study subjects with primary spontaneous ICH. The treating clinicians will&#xD;
      be blinded to the data collection and SENSE device scanning as described below.&#xD;
&#xD;
      All eligible subjects must have the diagnostic head CT scan (CT) demonstrating hemorrhage&#xD;
      performed within 6 hours of symptom onset. While ICH and TBI patients may be evaluated in&#xD;
      future studies, this early feasibility study is limited to primary spontaneous ICH patients&#xD;
      only, given the relative homogeneity of this population compared with the TBI population.&#xD;
&#xD;
      Eligible subjects or legally authorized representatives will be approached for enrollment.&#xD;
      After obtaining informed consent to participate in the study, a baseline study head CT will&#xD;
      be performed to establish the hemorrhage volume; and the SENSE device will be placed on the&#xD;
      subject within 15 minutes of this CT, or as soon as practicable, for initiation of&#xD;
      monitoring. This repeat CT (after the diagnostic CT) is necessary since hemorrhage expansion&#xD;
      (HE) occurs early in the clinical course, and the hemorrhage volume may have changed between&#xD;
      the diagnostic CT and placement of the SENSE monitor.&#xD;
&#xD;
      After enrollment, routine clinical management will ensue in the emergency department (ED),&#xD;
      hospital ward or intensive care unit (ICU) as appropriate. A standard of care head CT to&#xD;
      evaluate for HE will be performed at 12 (±6) hours after the baseline study head CT. Finally,&#xD;
      a study head CT will be performed at 72 (±12) hours to evaluate cerebral edema. Any head CT&#xD;
      performed for clinical deterioration as standard of care between the baseline and 72 hour&#xD;
      study CTs will also be collected and analyzed.&#xD;
&#xD;
      The SENSE device will be placed on the subject's head, and two small ink dots will be marked&#xD;
      on the head corresponding to a known location on the device to allow for the device to be&#xD;
      removed and replaced consistently throughout testing. The SENSE device will be set to scan&#xD;
      every 10 minutes until the device is removed after completion of the SENSE measurement&#xD;
      corresponding to the 72 hour CT scan. If the SENSE device is removed to perform the CT or&#xD;
      SENSE monitoring is temporarily suspended, the SENSE device will be replaced; and SENSE&#xD;
      monitoring will resume within 15 minutes, or as soon as practicable, after each CT scan. A&#xD;
      SENSE measurement obtained within 15 minutes of each CT scan, or as soon as practicable&#xD;
      thereafter, will be used for comparison with data analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Serious Device-related Adverse Events</measure>
    <time_frame>Up to 6 Weeks</time_frame>
    <description>Number of subjects who experienced a serious device-related adverse event or seizure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours.</measure>
    <time_frame>12 Hours</time_frame>
    <description>The SENSE device continuously monitored patients for hemorrhage expansion (HE) defined as a greater than 3 ml increase in ICH volume. ICH volumes were determined from the CT scans by a neuroradiologist. The concordance of SENSE determination of HE or NHE with the CT results was determined.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the SENSE Device in a Clinical Environment</measure>
    <time_frame>Up to 72 Hours</time_frame>
    <description>Number of patients where data was successfully acquired, downloaded, and analyzed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Intracerebral Hemorrhage</condition>
  <condition>Stroke, Acute</condition>
  <condition>Stroke Hemorrhagic</condition>
  <arm_group>
    <arm_group_label>SENSE Device Monitoring in ICH Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:&#xD;
A molded plastic headpiece containing the antenna array, and&#xD;
A processing control unit that contains:&#xD;
The driving electronics for the array;&#xD;
A spectrum analyzer coupled with a computer; and,&#xD;
The operating software that controls the device function and data acquisition, processing and archiving.&#xD;
For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SENSE Device</intervention_name>
    <description>The SENSE device transmits a low power tailored electro-magnetic pulse across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:&#xD;
A molded plastic headpiece containing the antenna array, and&#xD;
A processing control unit.&#xD;
The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.</description>
    <arm_group_label>SENSE Device Monitoring in ICH Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients age 22 years and older&#xD;
&#xD;
          2. Diagnostic head CT scan within 24 hours of primary spontaneous ICH symptom onset&#xD;
&#xD;
          3. ICH &gt;3mL and &lt;90mL, as measured by the ABC method&#xD;
&#xD;
          4. Signed written informed consent by study subject or, if subject is unable, by&#xD;
             subject's next of kin or legal guardian&#xD;
&#xD;
          5. Willingness and ability to comply with schedule for study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female patients who are pregnant or lactating&#xD;
&#xD;
          2. Patients with any history of seizure or seizure at stroke onset&#xD;
&#xD;
          3. Presence or history of any other condition or finding that, in the investigator's&#xD;
             opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring&#xD;
             or study participation or may confound the outcome of the study&#xD;
&#xD;
          4. Any intraventricular hemorrhage on the diagnostic (pre-enrollment) CT with planned&#xD;
             placement of an intraventricular catheter&#xD;
&#xD;
          5. Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma,&#xD;
             aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)&#xD;
&#xD;
          6. Planned withdrawal of care within 24 hours of enrollment&#xD;
&#xD;
          7. Planned surgical evacuation within 24 hours of enrollment&#xD;
&#xD;
          8. Current participation in a medical or surgical interventional clinical trial&#xD;
&#xD;
          9. Presence of subdural, epidural or aneurysmal subarachnoid hemorrhage on diagnostic&#xD;
             scan&#xD;
&#xD;
         10. Planned continued use or prescribed use during the study of medications that, in the&#xD;
             investigator's best clinical judgment, are known or suspected to lower the seizure&#xD;
             threshold&#xD;
&#xD;
         11. Planned continued use of medications that, in the investigator's best clinical&#xD;
             judgment, could increase the chances for subsequent uncontrolled hemorrhage&#xD;
&#xD;
         12. Planned or current use of continuous EEG monitoring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Knight, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <results_first_submitted>December 23, 2020</results_first_submitted>
  <results_first_submitted_qc>September 2, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 1, 2021</results_first_posted>
  <last_update_submitted>December 3, 2021</last_update_submitted>
  <last_update_submitted_qc>December 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</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>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Intracranial Hemorrhages</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03038087/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SENSE Device Monitoring in ICH Patients</title>
          <description>The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:&#xD;
A molded plastic headpiece containing the antenna array, and&#xD;
A processing control unit that contains:&#xD;
The driving electronics for the array;&#xD;
A spectrum analyzer coupled with a computer; and,&#xD;
The operating software that controls the device function and data acquisition, processing and archiving.&#xD;
For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.&#xD;
The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>lost data</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SENSE Device Monitoring in ICH Patients</title>
          <description>The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:&#xD;
A molded plastic headpiece containing the antenna array, and&#xD;
A processing control unit that contains:&#xD;
The driving electronics for the array;&#xD;
A spectrum analyzer coupled with a computer; and,&#xD;
The operating software that controls the device function and data acquisition, processing and archiving.&#xD;
For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.&#xD;
The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" lower_limit="43" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Serious Device-related Adverse Events</title>
        <description>Number of subjects who experienced a serious device-related adverse event or seizure.</description>
        <time_frame>Up to 6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Subjects Who Experienced Serious Device-related Adverse Events or Seizure.</title>
            <description>The number of subjects who experienced a device related serious AE and/or seizures will be tabulated and summarized.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Serious Device-related Adverse Events</title>
          <description>Number of subjects who experienced a serious device-related adverse event or seizure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours.</title>
        <description>The SENSE device continuously monitored patients for hemorrhage expansion (HE) defined as a greater than 3 ml increase in ICH volume. ICH volumes were determined from the CT scans by a neuroradiologist. The concordance of SENSE determination of HE or NHE with the CT results was determined.</description>
        <time_frame>12 Hours</time_frame>
        <population>Study subjects were drawn from patients suffering from ICH. These patients either presented or transferred to a large, urban, comprehensive stroke center.</population>
        <group_list>
          <group group_id="O1">
            <title>ICH Patients With Hemorrhage Expansion</title>
            <description>The primary aim was to determine determine the ability of the SENSE device to detect a clinically significant (&gt;= 3 ml) hemorrhage expansion in ICH patients. ICH volume was determined by CT measurements at 0, 12, and up to 72 hours (if available).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours.</title>
          <description>The SENSE device continuously monitored patients for hemorrhage expansion (HE) defined as a greater than 3 ml increase in ICH volume. ICH volumes were determined from the CT scans by a neuroradiologist. The concordance of SENSE determination of HE or NHE with the CT results was determined.</description>
          <population>Study subjects were drawn from patients suffering from ICH. These patients either presented or transferred to a large, urban, comprehensive stroke center.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ICH Subjects with expansion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICH Patients without expansion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Feasibility of the SENSE Device in a Clinical Environment</title>
        <description>Number of patients where data was successfully acquired, downloaded, and analyzed.</description>
        <time_frame>Up to 72 Hours</time_frame>
        <population>Patients were monitored with SENSE for an average of 60 (range: 23-72) hours. There were no serious adverse events. Minor adverse events were predominantly minor skin and nose irritation from the nosepiece of the headset. 1 Patient did not finish the study.</population>
        <group_list>
          <group group_id="O1">
            <title>SENSE Device Monitoring in ICH Patients</title>
            <description>The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:&#xD;
A molded plastic headpiece containing the antenna array, and&#xD;
A processing control unit that contains:&#xD;
The driving electronics for the array;&#xD;
A spectrum analyzer coupled with a computer; and,&#xD;
The operating software that controls the device function and data acquisition, processing and archiving.&#xD;
For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.&#xD;
The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of the SENSE Device in a Clinical Environment</title>
          <description>Number of patients where data was successfully acquired, downloaded, and analyzed.</description>
          <population>Patients were monitored with SENSE for an average of 60 (range: 23-72) hours. There were no serious adverse events. Minor adverse events were predominantly minor skin and nose irritation from the nosepiece of the headset. 1 Patient did not finish the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>SENSE Device Monitoring in ICH Patients</title>
          <description>The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:&#xD;
A molded plastic headpiece containing the antenna array, and&#xD;
A processing control unit that contains:&#xD;
The driving electronics for the array;&#xD;
A spectrum analyzer coupled with a computer; and,&#xD;
The operating software that controls the device function and data acquisition, processing and archiving.&#xD;
For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.&#xD;
The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <description>Redness caused by device pressing on skin and bridge of nose</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Joe Korfhagen</name_or_title>
      <organization>SENSE Diagnostics, Inc.</organization>
      <phone>844-373-6730</phone>
      <email>jkorfhagen@senseneuro.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03038087
org study id: SENSE-001
nct id: NCT03038087
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this research study is to find out whether a device for monitoring bleeding in
      patients with acute hemorrhagic stroke will show similar findings as CT scans performed to
      evaluate the stroke.
This will be a prospective, observational, single site, first-in-man study of the SENSE
      device in up to 10 study subjects with primary spontaneous ICH. The treating clinicians will
      be blinded to the data collection and SENSE device scanning as described below.

      All eligible subjects must have the diagnostic head CT scan (CT) demonstrating hemorrhage
      performed within 6 hours of symptom onset. While ICH and TBI patients may be evaluated in
      future studies, this early feasibility study is limited to primary spontaneous ICH patients
      only, given the relative homogeneity of this population compared with the TBI population.

      Eligible subjects or legally authorized representatives will be approached for enrollment.
      After obtaining informed consent to participate in the study, a baseline study head CT will
      be performed to establish the hemorrhage volume; and the SENSE device will be placed on the
      subject within 15 minutes of this CT, or as soon as practicable, for initiation of
      monitoring. This repeat CT (after the diagnostic CT) is necessary since hemorrhage expansion
      (HE) occurs early in the clinical course, and the hemorrhage volume may have changed between
      the diagnostic CT and placement of the SENSE monitor.

      After enrollment, routine clinical management will ensue in the emergency department (ED),
      hospital ward or intensive care unit (ICU) as appropriate. A standard of care head CT to
      evaluate for HE will be performed at 12 (±6) hours after the baseline study head CT. Finally,
      a study head CT will be performed at 72 (±12) hours to evaluate cerebral edema. Any head CT
      performed for clinical deterioration as standard of care between the baseline and 72 hour
      study CTs will also be collected and analyzed.

      The SENSE device will be placed on the subject's head, and two small ink dots will be marked
      on the head corresponding to a known location on the device to allow for the device to be
      removed and replaced consistently throughout testing. The SENSE device will be set to scan
      every 10 minutes until the device is removed after completion of the SENSE measurement
      corresponding to the 72 hour CT scan. If the SENSE device is removed to perform the CT or
      SENSE monitoring is temporarily suspended, the SENSE device will be replaced; and SENSE
      monitoring will resume within 15 minutes, or as soon as practicable, after each CT scan. A
      SENSE measurement obtained within 15 minutes of each CT scan, or as soon as practicable
      thereafter, will be used for comparison with data analysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of Patients With Serious Device-related Adverse Events
time frame: Up to 6 Weeks
description: Number of subjects who experienced a serious device-related adverse event or seizure.
measure: Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours.
time frame: 12 Hours
description: The SENSE device continuously monitored patients for hemorrhage expansion (HE) defined as a greater than 3 ml increase in ICH volume. ICH volumes were determined from the CT scans by a neuroradiologist. The concordance of SENSE determination of HE or NHE with the CT results was determined.
measure: Feasibility of the SENSE Device in a Clinical Environment
time frame: Up to 72 Hours
description: Number of patients where data was successfully acquired, downloaded, and analyzed.
arm group label: SENSE Device Monitoring in ICH Patients
arm group type: Experimental
description: The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:
A molded plastic headpiece containing the antenna array, and
A processing control unit that contains:
The driving electronics for the array;
A spectrum analyzer coupled with a computer; and,
The operating software that controls the device function and data acquisition, processing and archiving.
For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam.
intervention type: Device
intervention name: SENSE Device
description: The SENSE device transmits a low power tailored electro-magnetic pulse across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:
A molded plastic headpiece containing the antenna array, and
A processing control unit.
The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.
arm group label: SENSE Device Monitoring in ICH Patients
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: William Knight, MD
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Cerebral Hemorrhage
mesh term: Intracranial Hemorrhages
mesh term: Hemorrhagic Stroke
mesh term: Hemorrhage
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 