<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/NCT02996136</url>
  </required_header>
  <id_info>
    <org_study_id>FLU-001-15</org_study_id>
    <nct_id>NCT02996136</nct_id>
  </id_info>
  <brief_title>Assessment of the Clinical Performance of the ARROW-FLU System</brief_title>
  <official_title>Assessment of the Clinical Performance of the ARROW-FLU System for the Detection of Influenza A and B in Symptomatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sekisui Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beaufort CRO</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sekisui Diagnostics, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ARROW-FLU Influenza A&amp;B Test is an in vitro diagnostic immuno-chromatographic assay&#xD;
      intended for the qualitative detection of influenza A and influenza B viral nucleoprotein&#xD;
      antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended&#xD;
      to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This&#xD;
      test is not intended for the detection of influenza C viruses. A negative test is presumptive&#xD;
      and it is recommended these results be confirmed by cell culture of an FDA cleared molecular&#xD;
      device. Negative results do not preclude influenza virus infection and should not be used as&#xD;
      the sole basis for treatment or other management decisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicenter prospective study will include nasal and nasopharyngeal swabs collected from&#xD;
      patients who present with flu-like symptoms and have undergone routine testing for influenza&#xD;
      virus strain types A or B. The ARROW-FLU Influenza A&amp;B Test System qualitative results will&#xD;
      be compared to a reference method for identification of Influenza A or B to determine the&#xD;
      clinical sensitivity and specificity of the device.&#xD;
&#xD;
      The ARROW-FLU Influenza A&amp;B Test system will be performed at CLIA-waived and non-CLIA waived&#xD;
      clinical sites. Device operators at CLIA-waived sites will be untrained intended users (e.g.&#xD;
      nurses, physician assistants, medical assistants, etc).&#xD;
&#xD;
      A subject's participation in this study will consist of a single visit. Following completion&#xD;
      of the informed consent process and a review of Inclusion/Exclusion criteria to determine&#xD;
      eligibility, each subject will receive a unique study identification number. After standard&#xD;
      of care sampling, two (2) nasal or nasopharyngeal swabs will be obtained from each subject&#xD;
      enrolled in the study. The swabs will be collected from the same nostril and alternated in&#xD;
      their order of designation for testing (i.e. one for ARROW-FLU Influenza System testing and&#xD;
      the other for reference testing. Any swab specimens required for standard of care testing&#xD;
      will be collected prior to the specimens for this investigation. Investigational device&#xD;
      operators will be blinded to standard of care testing results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance of the ARROW-FLU Influenza Test</measure>
    <time_frame>Through study completion, an average of 5 months</time_frame>
    <description>The primary objective of this study is the characterization of the performance of the ARROW-FLU Influenza Test to detect influenza virus strain type A or type B in symptomatic subjects. Qualitative results obtained using the ARROW-FLU Influenza Test will be compared to a reference method or &quot;Gold Standard&quot; (viral culture and/or an FDA cleared molecular assay). Performance data generated will support a 510k submission to FDA for clearance of the assay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ability of untrained intended users to effectively perform the ARROW-FLU Influenza Test</measure>
    <time_frame>Through study completion, an average of 5 months</time_frame>
    <description>The secondary objective of this study is to demonstrate the ability of untrained intended users to effectively perform the ARROW-FLU Influenza A&amp;B Test with insignificant risk of erroneous results. Qualitative results obtained using the ARROW-FLU Influenza Test System will be compared to the reference method for confirmation of results on specimens collected during this study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Influenza, Human</condition>
  <arm_group>
    <arm_group_label>Nasal Swab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasal Swab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasopharyngeal Swab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nasopharyngeal Swab</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flu Symptoms</intervention_name>
    <description>Flu Symptoms</description>
    <arm_group_label>Nasal Swab</arm_group_label>
    <arm_group_label>Nasopharyngeal Swab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject may be of any age and either gender.&#xD;
&#xD;
          2. Preliminary assessment of the subject by the Investigator/Designee should be&#xD;
             suggestive of influenza virus infection. Subject should present with an influenza-like&#xD;
             febrile respiratory illness defined as both&#xD;
&#xD;
               -  Presentation within that last 48 hours of developing a subjective feeling of&#xD;
                  being feverish and/or a temperature recorded at the clinic within the last 48&#xD;
                  hours of greater than or equal to 100.5 F and&#xD;
&#xD;
               -  At least two of the following symptoms: cough, nasal congestion, rhinorrhea, sore&#xD;
                  throat, headache, myalgia.&#xD;
&#xD;
          3. Written informed consent must be obtained prior to study enrollment:&#xD;
&#xD;
               1. A subject who is 18 years or older must be willing to give written informed&#xD;
                  consent and must agree to comply with study procedures.&#xD;
&#xD;
               2. The legal authorized representative of a subject who is under the age of 18 must&#xD;
                  give written informed consent and agree to comply with study procedures. Active&#xD;
                  written assent should be obtained from children of appropriate intellectual age&#xD;
                  (as defined by the clinical site's IRB).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject underwent a nasal wash/aspirate as part of standard-of-care (SOC) testing&#xD;
             during this study visit.&#xD;
&#xD;
          2. The subject is undergoing treatment currently or within the past seven (7) days of the&#xD;
             study visit with either&#xD;
&#xD;
               -  A nasally-administered influenza vaccine (FluMist)&#xD;
&#xD;
               -  Anti-viral medication, which may include but is not limited to Amantadine&#xD;
                  (Symmetrel), Rimantadine (Flumadine), Zanamivir (Relenza), Oseltamivir (Tamiflu),&#xD;
                  or Ribavirin.&#xD;
&#xD;
          3. The subject is currently receiving or has received within the past thirty (30) days of&#xD;
             the study visit anu experimental biologic, drug, or device including either treatment&#xD;
             or therapy.&#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>Daiva Schmidt</last_name>
    <role>Study Director</role>
    <affiliation>Sekisui Diagnostics, LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Steven Grossman</last_name>
    <phone>781-652-7828</phone>
    <email>steven.grossman@sekisuidiagnostics.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Applied Research Center of Arkansas</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72212</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Steve Simpson, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Research of South Florida</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jeffrey Rosen, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sunrise Medical Research</name>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jason Haffizulla, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sacred Heart Hospital</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Donna Mayne, BS (MT) ASCP</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Indiana University School of Medicine</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Thomas Davis, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Dana King, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Avant Research Associates LLC</name>
      <address>
        <city>Crowley</city>
        <state>Louisiana</state>
        <zip>70526</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Satinder Saini, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tristan Medical Research Center / Regeneris Medical</name>
      <address>
        <city>North Attleboro</city>
        <state>Massachusetts</state>
        <zip>02760</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Ryan Welter, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Children's Mercy</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Rangaraj Selvarangan, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Accent Clinical Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Rogelio Machuca, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Wayne Harper, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Research Solutions LLC (Ohio)</name>
      <address>
        <city>Middleburg Heights</city>
        <state>Ohio</state>
        <zip>44130</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>John Panuto, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinical Research Solutions LLC (Tennessee)</name>
      <address>
        <city>Smyrna</city>
        <state>Tennessee</state>
        <zip>37167</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Sadia Dar, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54701</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Julia Kyle, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</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>
  <patient_data>
    <sharing_ipd>No</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/NCT02996136
org study id: FLU-001-15
nct id: NCT02996136
lead sponsor: 
collaborator: 
has dmc: No
The ARROW-FLU Influenza A&B Test is an in vitro diagnostic immuno-chromatographic assay
      intended for the qualitative detection of influenza A and influenza B viral nucleoprotein
      antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended
      to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This
      test is not intended for the detection of influenza C viruses. A negative test is presumptive
      and it is recommended these results be confirmed by cell culture of an FDA cleared molecular
      device. Negative results do not preclude influenza virus infection and should not be used as
      the sole basis for treatment or other management decisions.
This multicenter prospective study will include nasal and nasopharyngeal swabs collected from
      patients who present with flu-like symptoms and have undergone routine testing for influenza
      virus strain types A or B. The ARROW-FLU Influenza A&B Test System qualitative results will
      be compared to a reference method for identification of Influenza A or B to determine the
      clinical sensitivity and specificity of the device.

      The ARROW-FLU Influenza A&B Test system will be performed at CLIA-waived and non-CLIA waived
      clinical sites. Device operators at CLIA-waived sites will be untrained intended users (e.g.
      nurses, physician assistants, medical assistants, etc).

      A subject's participation in this study will consist of a single visit. Following completion
      of the informed consent process and a review of Inclusion/Exclusion criteria to determine
      eligibility, each subject will receive a unique study identification number. After standard
      of care sampling, two (2) nasal or nasopharyngeal swabs will be obtained from each subject
      enrolled in the study. The swabs will be collected from the same nostril and alternated in
      their order of designation for testing (i.e. one for ARROW-FLU Influenza System testing and
      the other for reference testing. Any swab specimens required for standard of care testing
      will be collected prior to the specimens for this investigation. Investigational device
      operators will be blinded to standard of care testing results.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Performance of the ARROW-FLU Influenza Test
time frame: Through study completion, an average of 5 months
description: The primary objective of this study is the characterization of the performance of the ARROW-FLU Influenza Test to detect influenza virus strain type A or type B in symptomatic subjects. Qualitative results obtained using the ARROW-FLU Influenza Test will be compared to a reference method or "Gold Standard" (viral culture and/or an FDA cleared molecular assay). Performance data generated will support a 510k submission to FDA for clearance of the assay.
measure: Ability of untrained intended users to effectively perform the ARROW-FLU Influenza Test
time frame: Through study completion, an average of 5 months
description: The secondary objective of this study is to demonstrate the ability of untrained intended users to effectively perform the ARROW-FLU Influenza A&B Test with insignificant risk of erroneous results. Qualitative results obtained using the ARROW-FLU Influenza Test System will be compared to the reference method for confirmation of results on specimens collected during this study.
arm group label: Nasal Swab
arm group type: Experimental
description: Nasal Swab
arm group label: Nasopharyngeal Swab
arm group type: Experimental
description: Nasopharyngeal Swab
intervention type: Device
intervention name: Flu Symptoms
description: Flu Symptoms
arm group label: Nasal Swab
arm group label: Nasopharyngeal Swab
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Daiva Schmidt
role: Study Director
affiliation: Sekisui Diagnostics, LLC
last name: Steven Grossman
phone: 781-652-7828
email: steven.grossman@sekisuidiagnostics.com
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country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No