<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/NCT04497610</url>
  </required_header>
  <id_info>
    <org_study_id>Tera-CR-1</org_study_id>
    <nct_id>NCT04497610</nct_id>
  </id_info>
  <brief_title>SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem</brief_title>
  <official_title>SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Costarricense de Investigaciones Clínicas ICIC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Costarricense de Investigaciones Clínicas ICIC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to verify the sensibility and accuracy of a rapid detection test&#xD;
      for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem,&#xD;
      comparing with PCR tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BioSafety Technologies has developed a rapid detection test to clear people of COVID-19.&#xD;
&#xD;
      A person can undergo an easy non-invasive test, to determine if they are: COVID-19 Clear&#xD;
      (Negative) or Infected (Positive). The user-friendly process does not involve medically&#xD;
      trained personnel.&#xD;
&#xD;
      The study will compare TeraSystem test results against PCR test results. Persons&#xD;
      participating will be persons having a PCR test as part of the Health System and consenting&#xD;
      to participate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not initiated&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 2022</start_date>
  <completion_date type="Anticipated">November 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Presence of disease</measure>
    <time_frame>1 minute</time_frame>
    <description>Established diagnosis</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>Positive TeraSystem test</arm_group_label>
    <description>Patients having positive PCR tests will undergo TeraSystem test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative TeraSystem test</arm_group_label>
    <description>Patients having negative PCR tests will undergo TeraSystem test</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Breath sample</intervention_name>
    <description>Patient will blow into a tube 5 times.</description>
    <arm_group_label>Negative TeraSystem test</arm_group_label>
    <arm_group_label>Positive TeraSystem test</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      breath sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Population under Country's screening program and known positive cases.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Older than 7 years odf age Able to provide informed consent Able to take the breath test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Younger than 7 years of age Unable to provide informed consent Unable to take the breath&#xD;
        test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Rodríguez Gómez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Founder and Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Costarricense de Investigaciones Clínicas</name>
      <address>
        <city>San José</city>
        <country>Costa Rica</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Costa Rica</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Costarricense de Investigaciones Clínicas ICIC</investigator_affiliation>
    <investigator_full_name>Dr. Guillermo Rodríguez Gómez</investigator_full_name>
    <investigator_title>Founder</investigator_title>
  </responsible_party>
  <keyword>SARS-CoV-2, coronavirus testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Personal data will be coded. No identifying information will be shared. Only demographic, and breath tests results will be shared.</ipd_description>
  </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/NCT04497610
org study id: Tera-CR-1
nct id: NCT04497610
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to verify the sensibility and accuracy of a rapid detection test
      for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem,
      comparing with PCR tests.
BioSafety Technologies has developed a rapid detection test to clear people of COVID-19.

      A person can undergo an easy non-invasive test, to determine if they are: COVID-19 Clear
      (Negative) or Infected (Positive). The user-friendly process does not involve medically
      trained personnel.

      The study will compare TeraSystem test results against PCR test results. Persons
      participating will be persons having a PCR test as part of the Health System and consenting
      to participate.
observational model: Cohort
time perspective: Prospective
measure: Presence of disease
time frame: 1 minute
description: Established diagnosis
arm group label: Positive TeraSystem test
description: Patients having positive PCR tests will undergo TeraSystem test
arm group label: Negative TeraSystem test
description: Patients having negative PCR tests will undergo TeraSystem test
intervention type: Diagnostic Test
intervention name: Breath sample
description: Patient will blow into a tube 5 times.
arm group label: Negative TeraSystem test
arm group label: Positive TeraSystem test
breath sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Guillermo Rodríguez Gómez, MD
role: Principal Investigator
affiliation: Founder and Investigator
facility: 
country: Costa Rica
responsible party type: Principal Investigator
investigator affiliation: Instituto Costarricense de Investigaciones Clínicas ICIC
investigator full name: Dr. Guillermo Rodríguez Gómez
investigator title: Founder
mesh term: COVID-19
sharing ipd: No
ipd description: Personal data will be coded. No identifying information will be shared. Only demographic, and breath tests results will be shared.