<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/NCT03035396</url>
  </required_header>
  <id_info>
    <org_study_id>DIA 01A-CLI-002</org_study_id>
    <nct_id>NCT03035396</nct_id>
  </id_info>
  <brief_title>Clinical Performance of the Diassess Influenza A and B Test</brief_title>
  <official_title>Clinical Performance of the Diassess Influenza A and B Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diassess Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diassess Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is device feasibility of the Diassess Influenza A and B&#xD;
      Test&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diassess test measurement agreement with Polymerase Chain Reaction (PCR)</measure>
    <time_frame>One (1) patient visit which is a time frame of one (1) hour</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">567</enrollment>
  <condition>Influenza, Human</condition>
  <condition>Influenza</condition>
  <condition>Flu</condition>
  <arm_group>
    <arm_group_label>Diassess Influenza A and B Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Diassess Influenza A and B Test</intervention_name>
    <arm_group_label>Diassess Influenza A and B Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is&#xD;
             currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs&#xD;
&#xD;
          -  Subject has at least one additional flu-like symptom including fever or feeling&#xD;
             feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired),&#xD;
             sore throat, headaches, or cough&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject received nasal vaccine (e.g. FluMist) within the past 10 days&#xD;
&#xD;
          -  Subject has been taking or took any antivirals for influenza in the past 30 days&#xD;
&#xD;
          -  Subject enrolled in any drug trials&#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>Carol Chen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Diassess Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Health Care Center</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 2, 2018</last_update_submitted>
  <last_update_submitted_qc>February 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</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>Influenza, Human</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/NCT03035396
org study id: DIA 01A-CLI-002
nct id: NCT03035396
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is device feasibility of the Diassess Influenza A and B
      Test
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
time frame: One (1) patient visit which is a time frame of one (1) hour
arm group label: Diassess Influenza A and B Test
arm group type: Experimental
intervention type: Device
intervention name: Diassess Influenza A and B Test
arm group label: Diassess Influenza A and B Test
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Carol Chen, PhD
role: Study Director
affiliation: Diassess Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human