<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/NCT04466501</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-ACR | LAB-MC-02</org_study_id>
    <nct_id>NCT04466501</nct_id>
  </id_info>
  <brief_title>ACR | LAB Urine Analysis Test System Evaluation of Performance</brief_title>
  <official_title>A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Healthy.io Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Healthy.io Ltd.</source>
  <oversight_info>
    <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 ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD)&#xD;
      device. The test is for the qualitative and semi- quantitative detection of Albumin,&#xD;
      Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a&#xD;
      smartphone application using an image recognition algorithm.&#xD;
&#xD;
      The degree of agreement of the ACR | LAB as compared to the comparator device will be tested.&#xD;
      Urine samples will be tested by a separate professional user on each device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.</measure>
    <time_frame>11 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">375</enrollment>
  <condition>Diabetes</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>ACR LAB for Professional User</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACR LAB</intervention_name>
    <description>The ACR | LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.</description>
    <arm_group_label>ACR LAB for Professional User</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women 18-80 years of age;&#xD;
&#xD;
          -  Subjects who are healthy or pregnant; or&#xD;
&#xD;
          -  Subjects diagnosed with a disease that normally represents itself with an abnormal&#xD;
             concentration of albumin:&#xD;
&#xD;
               -  Diabetes Type I/Type II,&#xD;
&#xD;
               -  Hypertension,&#xD;
&#xD;
               -  Any kidney disease,&#xD;
&#xD;
               -  Other relevant conditions.&#xD;
&#xD;
          -  Subjects with any pathological findings which might be identified by the urine test&#xD;
             (according to the physician discretion);&#xD;
&#xD;
          -  Subject is capable and willing to provide informed consent;&#xD;
&#xD;
          -  Subject has facility with both hands&#xD;
&#xD;
          -  Subject is capable and willing to adhere to the study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Kentucky Research Associates</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AccuMed research associates</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</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>Hypertension</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/NCT04466501
org study id: CTP-ACR | LAB-MC-02
nct id: NCT04466501
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD)
      device. The test is for the qualitative and semi- quantitative detection of Albumin,
      Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a
      smartphone application using an image recognition algorithm.

      The degree of agreement of the ACR | LAB as compared to the comparator device will be tested.
      Urine samples will be tested by a separate professional user on each device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.
time frame: 11 months
arm group label: ACR LAB for Professional User
arm group type: Experimental
intervention type: Device
intervention name: ACR LAB
description: The ACR | LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
arm group label: ACR LAB for Professional User
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension