<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/NCT03827720</url>
  </required_header>
  <id_info>
    <org_study_id>SENSE-002</org_study_id>
    <nct_id>NCT03827720</nct_id>
  </id_info>
  <brief_title>Early Feasibility Study of the SENSE Device</brief_title>
  <official_title>An Early Feasibility Study of the SENSE Device in Healthy Volunteers and Patients With Hemorrhagic Stroke, Ischemic Stroke With Large Vessel Occlusion, and Ischemic Stroke Without Large Vessel Occlusion</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>
      A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls&#xD;
      and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within&#xD;
      24 hours of stroke symptom onset.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single site, study of the SENSE device in up to 20 study subjects, (five&#xD;
      healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can&#xD;
      be applied within 24 hours of stroke symptom onset. LVO will be defined as occlusion of the&#xD;
      internal carotid artery (ICA) or middle cerebral artery (M1 or M2). All images in stroke&#xD;
      patients will be reviewed by an independent neuroradiologist and final diagnoses ascertained&#xD;
      by an independent neurologist. The treating clinicians will be blinded to the data collection&#xD;
      and SENSE device scanning as described below.&#xD;
&#xD;
      A history and physical examination will be performed by the treating physician, and routine&#xD;
      evaluations (including a diagnostic head CT/CT angiogram or MR/MR angiogram). All eligible&#xD;
      subjects must have the diagnostic head CT/MR scan and clinical diagnosis of a stroke (ICH,&#xD;
      AIS with LVO or AIS without LVO) performed within 24 hours of symptom onset.&#xD;
&#xD;
      Eligible subjects or legally authorized representatives will be approached for enrollment.&#xD;
      Prior to obtaining informed consent, concurrence of patients' eligibility for this study and&#xD;
      an assertion that the patient is clinically stable will be obtained from the treating team&#xD;
      and its attending physician prior to obtaining informed consent. After obtaining informed&#xD;
      consent to participate in the study, the SENSE device will be placed on the subject and&#xD;
      monitoring will proceed over 45 minutes. A research coordinator will be present at the&#xD;
      bedside for the 45 minutes of SENSE monitoring.&#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 with or&#xD;
      without CT angiography or MR with or without angiography performed prior to diagnosis will be&#xD;
      collected and analyzed. All enrolled AIS subjects must have a CT or MR angiography performed&#xD;
      within 24 hours to establish absence or presence of LVO. Study procedures shall not delay,&#xD;
      detract or interfere with medically necessary care or with planned treatments.&#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 the 45 minutes of testing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2019</start_date>
  <completion_date type="Actual">January 4, 2021</completion_date>
  <primary_completion_date type="Actual">November 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The Sensor Evaluation of Neurologic Status in Emergencies (SENSE) device (Sense Diagnostics LLC; Cincinnati, OH) is a non-invasive radiofrequency (RF) sensor that detects and monitors intracranial hemorrhage (ICH).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of SENSE signal with CT scan for stroke severity (location), hemorrhage volume (ABC method) and AIS LOV status (presence and location)</measure>
    <time_frame>45 minutes</time_frame>
    <description>The change in received power (PR) measured by the SENSE device will be calculated and the accuracy of the SENSE algorithm will be tested for the SENSE measurement that correspond with diagnostic CT scan for stroke severity, hemorrhage volume and in the case of AIS, presence or absence of LVO..</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants that completed the 45 mins monitoring session with the Sense Device successfully through confirmation that all planned data has been collected.</measure>
    <time_frame>45 minutes</time_frame>
    <description>The ability to process collected data in a manner that allows application and use of the SENSE device in a clinical environment through assessment of all participants that have complete SENSE Device data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events (AE), unanticipated adverse device effects (UADE) and serious adverse events (SAE) as defined in the protocol.</measure>
    <time_frame>7 days</time_frame>
    <description>Preliminary estimate of the safety of the device when used in a clinical setting through tabulation and summary of AEs, UADEs and SAEs.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hemorrhagic Stroke</condition>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers monitored with Sense Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intracranial Hemorrhage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intracranial hemorrhage patients monitored with Sense Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute Ischemic Stroke with LOV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acute Ischemic Stroke patients that have large vessel occlusion monitored with SENSE Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AIS without LOV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ischemic Stroke patients that do not have large vessel occlusion monitored with SENSE device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SENSE Device</intervention_name>
    <description>Non-invasive radiofrequency (RF) sensor</description>
    <arm_group_label>AIS without LOV</arm_group_label>
    <arm_group_label>Acute Ischemic Stroke with LOV</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intracranial Hemorrhage</arm_group_label>
    <other_name>CT Scan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients age 22 years and older&#xD;
&#xD;
          2. Established diagnosis of AIS (with or without LVO) or ICH within 24 hours of symptom&#xD;
             onset&#xD;
&#xD;
          3. Signed written informed consent by study subject or, if subject is unable, by&#xD;
             subject's next of kin or legal guardian&#xD;
&#xD;
          4. Willingness and ability to comply with 45 minutes of SENSE monitoring per study&#xD;
             procedures&#xD;
&#xD;
          5. Attending (Treating) physician has indicated that the patient is stable and has&#xD;
             approved the patient's participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female patients who are pregnant or lactating&#xD;
&#xD;
          2. Patients with a known seizure disorder or those who have a 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. Intraventricular hemorrhage requiring emergent ventriculostomy placement on the&#xD;
             eligibility CT or MRI&#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. Pontine or infratentorial location of ICH&#xD;
&#xD;
          7. In AIS patients, treatment with intravenous alteplase and/or mechanical thrombectomy&#xD;
             prior to the initiation of 45 minutes of SENSE monitoring&#xD;
&#xD;
          8. Current participation in an interventional clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Ringer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth Hatton Research Institute - Good Samaritan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TriHealth Hatton Research Institute - Good Samaritan Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Health</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>July 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>July 1, 2021</last_update_submitted>
  <last_update_submitted_qc>July 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 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>Ischemic Stroke</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
    <mesh_term>Ischemia</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/NCT03827720
org study id: SENSE-002
nct id: NCT03827720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls
      and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within
      24 hours of stroke symptom onset.
This will be a single site, study of the SENSE device in up to 20 study subjects, (five
      healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can
      be applied within 24 hours of stroke symptom onset. LVO will be defined as occlusion of the
      internal carotid artery (ICA) or middle cerebral artery (M1 or M2). All images in stroke
      patients will be reviewed by an independent neuroradiologist and final diagnoses ascertained
      by an independent neurologist. The treating clinicians will be blinded to the data collection
      and SENSE device scanning as described below.

      A history and physical examination will be performed by the treating physician, and routine
      evaluations (including a diagnostic head CT/CT angiogram or MR/MR angiogram). All eligible
      subjects must have the diagnostic head CT/MR scan and clinical diagnosis of a stroke (ICH,
      AIS with LVO or AIS without LVO) performed within 24 hours of symptom onset.

      Eligible subjects or legally authorized representatives will be approached for enrollment.
      Prior to obtaining informed consent, concurrence of patients' eligibility for this study and
      an assertion that the patient is clinically stable will be obtained from the treating team
      and its attending physician prior to obtaining informed consent. After obtaining informed
      consent to participate in the study, the SENSE device will be placed on the subject and
      monitoring will proceed over 45 minutes. A research coordinator will be present at the
      bedside for the 45 minutes of SENSE monitoring.

      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 with or
      without CT angiography or MR with or without angiography performed prior to diagnosis will be
      collected and analyzed. All enrolled AIS subjects must have a CT or MR angiography performed
      within 24 hours to establish absence or presence of LVO. Study procedures shall not delay,
      detract or interfere with medically necessary care or with planned treatments.

      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 the 45 minutes of testing.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The Sensor Evaluation of Neurologic Status in Emergencies (SENSE) device (Sense Diagnostics LLC; Cincinnati, OH) is a non-invasive radiofrequency (RF) sensor that detects and monitors intracranial hemorrhage (ICH).
primary purpose: Other
masking: None (Open Label)
measure: Correlation of SENSE signal with CT scan for stroke severity (location), hemorrhage volume (ABC method) and AIS LOV status (presence and location)
time frame: 45 minutes
description: The change in received power (PR) measured by the SENSE device will be calculated and the accuracy of the SENSE algorithm will be tested for the SENSE measurement that correspond with diagnostic CT scan for stroke severity, hemorrhage volume and in the case of AIS, presence or absence of LVO..
measure: Number of participants that completed the 45 mins monitoring session with the Sense Device successfully through confirmation that all planned data has been collected.
time frame: 45 minutes
description: The ability to process collected data in a manner that allows application and use of the SENSE device in a clinical environment through assessment of all participants that have complete SENSE Device data.
measure: Number of participants with adverse events (AE), unanticipated adverse device effects (UADE) and serious adverse events (SAE) as defined in the protocol.
time frame: 7 days
description: Preliminary estimate of the safety of the device when used in a clinical setting through tabulation and summary of AEs, UADEs and SAEs.
arm group label: Control
arm group type: Experimental
description: Healthy volunteers monitored with Sense Device
arm group label: Intracranial Hemorrhage
arm group type: Experimental
description: Intracranial hemorrhage patients monitored with Sense Device
arm group label: Acute Ischemic Stroke with LOV
arm group type: Experimental
description: Acute Ischemic Stroke patients that have large vessel occlusion monitored with SENSE Device
arm group label: AIS without LOV
arm group type: Experimental
description: Ischemic Stroke patients that do not have large vessel occlusion monitored with SENSE device
intervention type: Device
intervention name: SENSE Device
description: Non-invasive radiofrequency (RF) sensor
arm group label: AIS without LOV
arm group label: Acute Ischemic Stroke with LOV
arm group label: Control
arm group label: Intracranial Hemorrhage
other name: CT Scan
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Ringer, MD
role: Principal Investigator
affiliation: TriHealth Hatton Research Institute - Good Samaritan Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Hemorrhagic Stroke
mesh term: Ischemia