<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/NCT03777098</url>
  </required_header>
  <id_info>
    <org_study_id>01-2018</org_study_id>
    <nct_id>NCT03777098</nct_id>
  </id_info>
  <brief_title>Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis</brief_title>
  <official_title>Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David A. Talan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Light AI, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Olive View-UCLA Education &amp; Research Institute</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 objective of this pilot study is to acquire images using the Strepic® device, a clinical&#xD;
      prototype that has been designed specifically as a viable, low-cost, commercially realizable&#xD;
      autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image&#xD;
      data, as well as other clinical data points. By acquiring and analyzing the images of&#xD;
      pharyngeal bacterial fluorescence and white light patterns in patients with Group A&#xD;
      Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS&#xD;
      pharyngitis, it is believed an algorithm can be developed such that the device will improve&#xD;
      the ability of clinicians to quickly and accurately identify GAS infections.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Strepic Device Image</measure>
    <time_frame>Day 1</time_frame>
    <description>A picture of the participant's throat will be obtained at enrollment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Throat culture or PCR result</measure>
    <time_frame>Day 2</time_frame>
    <description>The results of throat culture or PCR (depending on the site) will be recorded and compared to the Strepic Device image findings</description>
  </primary_outcome>
  <enrollment type="Actual">426</enrollment>
  <condition>Group A Streptococcal Infection</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Strepic® Device</intervention_name>
    <description>The Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to participating U.S. emergency departments or clinics with complaint&#xD;
        of pharyngitis will be screened.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients aged 7-64 years of age with suspected GAS pharyngitis with modified&#xD;
             Centor (McIsaac) score ≥2; and&#xD;
&#xD;
          2. Patient agrees to participate in study and patient or parent/guardian sign&#xD;
             consent/assent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pharyngeal swab performed immediately prior to study team approach;&#xD;
&#xD;
          2. Prior enrollment in this study;&#xD;
&#xD;
          3. Pharyngeal symptoms &gt;7 days;&#xD;
&#xD;
          4. Peritonsillar abscess;&#xD;
&#xD;
          5. Antibiotic use within one week of index visit;&#xD;
&#xD;
          6. Inability to open mouth to visualize the pharynx; and&#xD;
&#xD;
          7. Inability to understand English or Spanish, as study forms including consent and&#xD;
             assent forms will be written in English and Spanish;&#xD;
&#xD;
          8. Woman who is pregnant (self-reported, pregnancy test will not be performed) or&#xD;
             nursing;&#xD;
&#xD;
          9. Current prisoner (define as an individual involuntarily confined in a penal&#xD;
             institution, including persons: (1) sentenced under a criminal or civil statue; (2)&#xD;
             detained pending arraignment, trial, or sentencing; and (3) detained in other&#xD;
             facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes&#xD;
             or commitment procedures providing such alternatives to criminal prosecution or&#xD;
             incarceration in a penal institution).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory Moran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Olive View-UCLA Education &amp; Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Olive View-UCLA Medical Center</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Olive View-UCLA Education &amp; Research Institute</investigator_affiliation>
    <investigator_full_name>David A. Talan</investigator_full_name>
    <investigator_title>Co-PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
    <mesh_term>Streptococcal Infections</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/NCT03777098
org study id: 01-2018
nct id: NCT03777098
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this pilot study is to acquire images using the Strepic® device, a clinical
      prototype that has been designed specifically as a viable, low-cost, commercially realizable
      autofluorescence-based diagnostic test, using (1) fluorescence and (2) white light image
      data, as well as other clinical data points. By acquiring and analyzing the images of
      pharyngeal bacterial fluorescence and white light patterns in patients with Group A
      Streptococcus (GAS)-associated pharyngitis and comparing them with those observed in non-GAS
      pharyngitis, it is believed an algorithm can be developed such that the device will improve
      the ability of clinicians to quickly and accurately identify GAS infections.
observational model: Case-Only
time perspective: Prospective
measure: Strepic Device Image
time frame: Day 1
description: A picture of the participant's throat will be obtained at enrollment.
measure: Throat culture or PCR result
time frame: Day 2
description: The results of throat culture or PCR (depending on the site) will be recorded and compared to the Strepic Device image findings
intervention type: Device
intervention name: Strepic® Device
description: The Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 64 Years
healthy volunteers: No
last name: Gregory Moran, MD
role: Principal Investigator
affiliation: Olive View-UCLA Education & Research Institute
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Olive View-UCLA Education & Research Institute
investigator full name: David A. Talan
investigator title: Co-PI
mesh term: Pharyngitis
mesh term: Streptococcal Infections
sharing ipd: No