<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/NCT04505293</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00087011_1</org_study_id>
    <nct_id>NCT04505293</nct_id>
  </id_info>
  <brief_title>Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas</brief_title>
  <official_title>Assessment of Accuracy, Precision, and Feasibility of a Handheld Near-Infrared Light Device (InfraScanner 2000™) in Detecting Subdural and Epidural Hematomas in Patients Admitted to Duke University Hospital and Mbarara Regional Referral Hospital: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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 goal of this study is to determine the sensitivity, specificity, and positive and&#xD;
      negative predictive values of the a portable near-infrared-based device (portable NIR-based&#xD;
      device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH)&#xD;
      and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral&#xD;
      Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When applicable (conscious patient and/or family or legally authorized representative is&#xD;
      present) the study will be introduced to the patient and relevant parties prior to the&#xD;
      research team approaching the patient. While head trauma frequently results in impaired&#xD;
      cognition and/or consciousness, and due to the urgency of these circumstances patients are&#xD;
      often not accompanied by kin, whenever appropriate, the purpose of the research and the&#xD;
      procedure will be explained in detail with all questions answered to the patient's and/or&#xD;
      representative's satisfaction. Because patients who sustain head trauma injuries typically&#xD;
      remain within the hospital for multiple days for monitoring and care, each participant may&#xD;
      undergo multiple Computed Tomography (CT) scans over the course of his or her&#xD;
      hospitalization, affording the opportunity of one to numerous measurements from each patient&#xD;
      during his or her hospital stay.&#xD;
&#xD;
      Upon presentation to the casualty unit at MRRH and following each CT scan, the study team&#xD;
      will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image&#xD;
      A). If permission is granted, the study team member sequentially measure the optical&#xD;
      absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and&#xD;
      occipital bilaterally) (Image B). The device is engineered such that the light emitter and&#xD;
      receiver are spaced 4 cm apart, allowing the light's intensity to be measured between&#xD;
      adjacent light guides (Image C). This entire procedure, including greeting and scanning the&#xD;
      patient should take &lt;10 minutes. Subsequent CT scan(s) the patient receives determines the&#xD;
      number of potential data collections.&#xD;
&#xD;
      The patient and/or representative may refuse a scan during any encounter, and as such, the&#xD;
      scan will not be done. For each patient scanned with the InfraScanner 2000™ they will be&#xD;
      de-identified with a subject number, with age, sex, gender, skin color, hair color, hair&#xD;
      thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT&#xD;
      scan and near-infrared measurement. These data will be stored in de-identified form on the&#xD;
      Research Electronic Data Capture (REDCap) database and/or Microsoft Excel 2016 on a secured&#xD;
      network drive within the Department of Neurosurgery at Duke.&#xD;
&#xD;
      The collection period for each research subject concludes 30-days following his or her&#xD;
      initial measurement with the InfraScanner 2000™, patient discharge, or patient death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2021</start_date>
  <completion_date type="Actual">August 5, 2022</completion_date>
  <primary_completion_date type="Actual">June 29, 2022</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of hematomas</measure>
    <time_frame>Within 30 minutes following each CT scan</time_frame>
    <description>Determine whether the InfraScanner 2000™ detects epidural and/or subdural hematomas with adequate precision relative to CT scans to be used as a diagnostic tool for epidural and/or subdural hematomas.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimate test characteristics</measure>
    <time_frame>18 months after study is closed to accrual</time_frame>
    <description>Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume &gt;3.5 mL and depth &lt;2.5 cm) compared to CT scan results as the gold standard.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate patient outcomes</measure>
    <time_frame>Through study completion, defined as 30 days following discharge</time_frame>
    <description>Clinical patient outcomes as measured by the Glasgow Outcomes Scale at discharge and 30 days post-discharge. The Glasgow Outcomes Scale is rated from 1 to 8, 1 being death, and 8 being upper good recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify reasons CT not performed</measure>
    <time_frame>Through study completion, defined as 30 days following discharge</time_frame>
    <description>CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify causes of head trauma</measure>
    <time_frame>Through study completion, defined as 30 days following discharge</time_frame>
    <description>Causes of head trauma will be identified through the medical record</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">672</enrollment>
  <condition>Head Trauma</condition>
  <condition>Craniocerebral Injuries</condition>
  <condition>Crushing Skull Injury</condition>
  <condition>Head Injuries</condition>
  <condition>Head Injuries, Multiple</condition>
  <condition>Head Injuries, Closed</condition>
  <condition>Head Trauma,Closed</condition>
  <condition>Head Trauma Injury</condition>
  <condition>Head Trauma, Penetrating</condition>
  <condition>Head Injury, Minor</condition>
  <condition>Head Injury Major</condition>
  <condition>Head Injury, Open</condition>
  <condition>Injuries, Craniocerebral</condition>
  <condition>Injuries, Head</condition>
  <condition>Multiple Head Injury</condition>
  <condition>Trauma, Head</condition>
  <arm_group>
    <arm_group_label>InfraScanner 2000™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InfraScanner 2000™</intervention_name>
    <description>The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.</description>
    <arm_group_label>InfraScanner 2000™</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient who presents to MRRH with suspected head trauma, who is able to or who has&#xD;
             a legally authorized representative who is able consent in English, Swahili, or&#xD;
             Luganda will be considered for this 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>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Haglund, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mbarara Regional Referral Hospital</name>
      <address>
        <city>Mbarara</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 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>Craniocerebral Trauma</mesh_term>
    <mesh_term>Hematoma, Epidural, Cranial</mesh_term>
    <mesh_term>Head Injuries, Closed</mesh_term>
    <mesh_term>Head Injuries, Penetrating</mesh_term>
    <mesh_term>Hematoma</mesh_term>
    <mesh_term>Hematoma, Epidural, Spinal</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Multiple Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 6, 2023</submitted>
    <returned>June 27, 2023</returned>
    <submitted>July 26, 2023</submitted>
    <returned>August 18, 2023</returned>
  </pending_results>
  <!-- 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/NCT04505293
org study id: Pro00087011_1
nct id: NCT04505293
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The goal of this study is to determine the sensitivity, specificity, and positive and
      negative predictive values of the a portable near-infrared-based device (portable NIR-based
      device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH)
      and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral
      Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
When applicable (conscious patient and/or family or legally authorized representative is
      present) the study will be introduced to the patient and relevant parties prior to the
      research team approaching the patient. While head trauma frequently results in impaired
      cognition and/or consciousness, and due to the urgency of these circumstances patients are
      often not accompanied by kin, whenever appropriate, the purpose of the research and the
      procedure will be explained in detail with all questions answered to the patient's and/or
      representative's satisfaction. Because patients who sustain head trauma injuries typically
      remain within the hospital for multiple days for monitoring and care, each participant may
      undergo multiple Computed Tomography (CT) scans over the course of his or her
      hospitalization, affording the opportunity of one to numerous measurements from each patient
      during his or her hospital stay.

      Upon presentation to the casualty unit at MRRH and following each CT scan, the study team
      will approach the patient to scan the patient's cranium with the InfraScanner 2000™ (Image
      A). If permission is granted, the study team member sequentially measure the optical
      absorption for each of the 8 quadrants of the scalp (frontal, temporal, parietal, and
      occipital bilaterally) (Image B). The device is engineered such that the light emitter and
      receiver are spaced 4 cm apart, allowing the light's intensity to be measured between
      adjacent light guides (Image C). This entire procedure, including greeting and scanning the
      patient should take <10 minutes. Subsequent CT scan(s) the patient receives determines the
      number of potential data collections.

      The patient and/or representative may refuse a scan during any encounter, and as such, the
      scan will not be done. For each patient scanned with the InfraScanner 2000™ they will be
      de-identified with a subject number, with age, sex, gender, skin color, hair color, hair
      thickness, mechanism of injury, Glasgow Coma Scale score, and mean time elapsed between CT
      scan and near-infrared measurement. These data will be stored in de-identified form on the
      Research Electronic Data Capture (REDCap) database and/or Microsoft Excel 2016 on a secured
      network drive within the Department of Neurosurgery at Duke.

      The collection period for each research subject concludes 30-days following his or her
      initial measurement with the InfraScanner 2000™, patient discharge, or patient death.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Detection of hematomas
time frame: Within 30 minutes following each CT scan
description: Determine whether the InfraScanner 2000™ detects epidural and/or subdural hematomas with adequate precision relative to CT scans to be used as a diagnostic tool for epidural and/or subdural hematomas.
measure: Estimate test characteristics
time frame: 18 months after study is closed to accrual
description: Test characteristics of the InfraScanner 2000™ in identification of hematomas within its detection limits (volume >3.5 mL and depth <2.5 cm) compared to CT scan results as the gold standard.
measure: Estimate patient outcomes
time frame: Through study completion, defined as 30 days following discharge
description: Clinical patient outcomes as measured by the Glasgow Outcomes Scale at discharge and 30 days post-discharge. The Glasgow Outcomes Scale is rated from 1 to 8, 1 being death, and 8 being upper good recovery.
measure: Identify reasons CT not performed
time frame: Through study completion, defined as 30 days following discharge
description: CT Scans that are ordered and not performed will have a medical record review to determine the reasons for the missed CT.
measure: Identify causes of head trauma
time frame: Through study completion, defined as 30 days following discharge
description: Causes of head trauma will be identified through the medical record
arm group label: InfraScanner 2000™
arm group type: Experimental
description: All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ upon arrival to the casualty unit at MRRH following CT. Patients will be scanned using the InfraScanner 2000™ following each subsequent CT as allowed by patient or representative. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
intervention type: Device
intervention name: InfraScanner 2000™
description: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
arm group label: InfraScanner 2000™
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michael Haglund, MD, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
country: Uganda
country: United States
responsible party type: Sponsor
mesh term: Craniocerebral Trauma
mesh term: Hematoma, Epidural, Cranial
mesh term: Head Injuries, Closed
mesh term: Head Injuries, Penetrating
mesh term: Hematoma
mesh term: Hematoma, Epidural, Spinal
mesh term: Wounds and Injuries
mesh term: Multiple Trauma
sharing ipd: No
submitted: June 6, 2023
returned: June 27, 2023
submitted: July 26, 2023
returned: August 18, 2023