<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/NCT04478812</url>
  </required_header>
  <id_info>
    <org_study_id>BDI-TBIT-04</org_study_id>
    <nct_id>NCT04478812</nct_id>
  </id_info>
  <brief_title>Tbit System Precision and Correlation of Different Blood Samples</brief_title>
  <official_title>A Prospective, Multi-Center, Blood Collection Study to Evaluate TbitTM System Precision and Correlation Between Different Blood Samples Measured With TbitTM System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioDirection Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NanoDx</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce&#xD;
      and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and&#xD;
      one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™&#xD;
      System by 3 different operators.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 15, 2022</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 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>Measurement Repeatability</measure>
    <time_frame>within 12 hours from injury for Tbit and within 30 min from the sample drawn</time_frame>
    <description>1. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare Measurements</measure>
    <time_frame>within 12 hours from injury</time_frame>
    <description>2. Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">81</enrollment>
  <condition>Brain Injuries</condition>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Single Group Assignment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Single Group Assignment</intervention_name>
    <description>Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected</description>
    <arm_group_label>Single Group Assignment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Presents to the Emergency Department with suspected traumatic brain injury&#xD;
&#xD;
          -  Blood sample collected for Tbit™ System within 12 hours of injury&#xD;
&#xD;
          -  Willing and able to provide informed consent or obtain consent from legal authorized&#xD;
             representative (LAR)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on&#xD;
             ED examination&#xD;
&#xD;
          -  Subject suspect of need of craniotomy for the acute trauma for this event&#xD;
&#xD;
          -  External signs compatible with a depressed skull fracture based on ED exam&#xD;
&#xD;
          -  Subject requiring administration of blood transfusion after injury and prior to study&#xD;
             blood draw&#xD;
&#xD;
          -  Subject for whom timing of injury is unable to be estimated within 1 hour of certainty&#xD;
&#xD;
          -  Subject who had neurodegenerative disease or other neurological disorder including&#xD;
             dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or&#xD;
             TIA within the last 30 days, or history of neurosurgery&#xD;
&#xD;
          -  Known or suspected to be pregnant&#xD;
&#xD;
          -  Prisoner or under incarceration&#xD;
&#xD;
          -  Participating in another clinical research study prior to this study completion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jerika Acosta, BSc</last_name>
    <role>Study Director</role>
    <affiliation>Medicept Inc</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lelia A Paunescu, PhD</last_name>
    <phone>7815268152</phone>
    <email>apaunescu@medicept.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Travis Jones, BSc</last_name>
    <phone>6783207670</phone>
    <email>tjones@medicept.com</email>
  </overall_contact_backup>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>January 26, 2022</last_update_submitted>
  <last_update_submitted_qc>January 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 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>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04478812
org study id: BDI-TBIT-04
nct id: NCT04478812
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce
      and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and
      one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™
      System by 3 different operators.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measurement Repeatability
time frame: within 12 hours from injury for Tbit and within 30 min from the sample drawn
description: 1. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment.
measure: Compare Measurements
time frame: within 12 hours from injury
description: 2. Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment.
arm group label: Single Group Assignment
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Single Group Assignment
description: Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected
arm group label: Single Group Assignment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jerika Acosta, BSc
role: Study Director
affiliation: Medicept Inc
last name: Lelia A Paunescu, PhD
phone: 7815268152
email: apaunescu@medicept.com
last name: Travis Jones, BSc
phone: 6783207670
email: tjones@medicept.com
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: Undecided