xml: <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/NCT05981495</url>
    </required_header>
    <id_info>
      <org_study_id>NanoDetect-TB_01</org_study_id>
      <nct_id>NCT05981495</nct_id>
    </id_info>
    <brief_title>Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease</brief_title>
    <official_title>Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NanoPin Technologies, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fortrea</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>NanoPin Technologies, Inc.</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in&#xD;
        diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals&#xD;
        suspected to have TB disease.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  How does this investigational device compare to the gold standard for TB diagnosis of&#xD;
             sputum culture?&#xD;
  &#xD;
          -  How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT&#xD;
             TB diagnostic assays?&#xD;
  &#xD;
        Participants will be asked to have blood drawn and provide demographic and medical data for&#xD;
        this study in a single visit.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>NanoDetect-TB result compared to sputum culture</measure>
      <time_frame>Single visit for patient for blood draw.</time_frame>
      <description>The investigational device results will be compared to the primary reference of sputum culture for determining relative sensitivity and specificity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>NanoDetect-TB result compared to AFB Smear and NAAT</measure>
      <time_frame>Single visit for patient for blood draw.</time_frame>
      <description>The investigational device results will be further compared to the AFB Smear and NAAT for determining relative sensitivity and specificity.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">460</enrollment>
    <condition>Tuberculosis, Pulmonary</condition>
    <condition>Tuberculosis, Extrapulmonary</condition>
    <condition>Tuberculosis Active</condition>
    <arm_group>
      <arm_group_label>TB Suspects</arm_group_label>
      <description>TB Suspects recruited to this study will have blood drawn in a single visit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NanoDetect-TB</intervention_name>
      <description>This study of the NanoDetect-TB investigational device will test plasma and serum samples from TB suspects. There is no intervention for the subjects and there will be a single visit blood draw.</description>
      <arm_group_label>TB Suspects</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma and Serum samples&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          TB suspects at clinical sites for recruitment in Houston, Miami, and New York City.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children and adults aged two years or older (including older adults that are 65+)&#xD;
  &#xD;
            -  Ability and willingness to provide informed consent/assent/permission, and a&#xD;
               parent/legal guardian willing to give consent on the child's behalf for study&#xD;
               participants aged 2-17 years&#xD;
  &#xD;
            -  Ability and willingness to perform study procedures, or parent/legal guardian to&#xD;
               provide consent for a child to undergo study procedures on their behalf (when&#xD;
               applicable)&#xD;
  &#xD;
            -  Clinical signs and symptoms typically associated with active TB disease including, but&#xD;
               not limited to:&#xD;
  &#xD;
          Cough for &gt; two (2) weeks Lethargy, weakness, malaise Reduced playfulness (pediatric&#xD;
          population) Weight loss or loss of appetite Failure to thrive (pediatric population) Fever&#xD;
          Chest pain Night sweats&#xD;
  &#xD;
            -  Physician (or healthcare provider) suspicion of TB disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy (based on participant-provided information)&#xD;
  &#xD;
            -  Any physical or mental health condition for which participation in the study, as&#xD;
               judged by the investigator, could compromise the well-being of the subject and/or&#xD;
               prevent, limit, or confound protocol-specified procedures&#xD;
  &#xD;
            -  Critical illness needing immediate medical care&#xD;
  &#xD;
            -  Receipt of treatment for active TB or LTBI in the past 24 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Thomas Tombler, Ph.D.</last_name>
      <phone>18056800377</phone>
      <email>ttombler@nanopintech.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</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>Tuberculosis</mesh_term>
      <mesh_term>Tuberculosis, Pulmonary</mesh_term>
      <mesh_term>Tuberculosis, Extrapulmonary</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981495
  org study id: NanoDetect-TB_01
  nct id: NCT05981495
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in
        diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals
        suspected to have TB disease.
  
        The main question[s] it aims to answer are:
  
          -  How does this investigational device compare to the gold standard for TB diagnosis of
             sputum culture?
  
          -  How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT
             TB diagnostic assays?
  
        Participants will be asked to have blood drawn and provide demographic and medical data for
        this study in a single visit.
  observational model: Cohort
  time perspective: Prospective
  measure: NanoDetect-TB result compared to sputum culture
  time frame: Single visit for patient for blood draw.
  description: The investigational device results will be compared to the primary reference of sputum culture for determining relative sensitivity and specificity.
  measure: NanoDetect-TB result compared to AFB Smear and NAAT
  time frame: Single visit for patient for blood draw.
  description: The investigational device results will be further compared to the AFB Smear and NAAT for determining relative sensitivity and specificity.
  arm group label: TB Suspects
  description: TB Suspects recruited to this study will have blood drawn in a single visit.
  intervention type: Device
  intervention name: NanoDetect-TB
  description: This study of the NanoDetect-TB investigational device will test plasma and serum samples from TB suspects. There is no intervention for the subjects and there will be a single visit blood draw.
  arm group label: TB Suspects
  Plasma and Serum samples
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Thomas Tombler, Ph.D.
  phone: 18056800377
  email: ttombler@nanopintech.com
  responsible party type: Sponsor
  mesh term: Tuberculosis
  mesh term: Tuberculosis, Pulmonary
  mesh term: Tuberculosis, Extrapulmonary
  sharing ipd: No