<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/NCT04465682</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol CTP-Healthy.io-01</org_study_id>
    <nct_id>NCT04465682</nct_id>
  </id_info>
  <brief_title>Dip Home-Based Dipstick Analyzer Performance Evaluation</brief_title>
  <official_title>A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone&#xD;
      application. The device will be provided to the subject in a simulated home-use environment.&#xD;
      All subjects will be asked to complete the urine test by following the application guidance,&#xD;
      including providing a urine sample and scanning the urine strip after placing it on the&#xD;
      Color-Board. The user will also complete a questionnaire to collect information regarding the&#xD;
      use of the HBDA device. Following the usability test performed by the lay user, the subject's&#xD;
      urine sample will be tested by the professional user using the comparator device. The use of&#xD;
      the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable&#xD;
      usability criteria for specific, critical steps will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2018</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.</measure>
    <time_frame>11 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions</measure>
    <time_frame>11 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Urine Detectable Acute and Chronic Diseases</condition>
  <arm_group>
    <arm_group_label>Dip Home-Based Dipstick Analyzer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm. Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Experimental: Dip Home-Based Dipstick Analyzer</intervention_name>
    <description>Dip Home-Based Dipstick Analyzer The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.</description>
    <arm_group_label>Dip Home-Based Dipstick Analyzer</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 one of the following urine analytes; Glucose, Bilirubin, Ketone&#xD;
             (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes,&#xD;
             and Nitrite&#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>Activmed Practices &amp; Research, Inc.</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</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>Chronic Disease</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/NCT04465682
org study id: Protocol CTP-Healthy.io-01
nct id: NCT04465682
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The Dip Home-Based Dipstick Analyzer (henceforth HBDA) is composed of a kit and a smartphone
      application. The device will be provided to the subject in a simulated home-use environment.
      All subjects will be asked to complete the urine test by following the application guidance,
      including providing a urine sample and scanning the urine strip after placing it on the
      Color-Board. The user will also complete a questionnaire to collect information regarding the
      use of the HBDA device. Following the usability test performed by the lay user, the subject's
      urine sample will be tested by the professional user using the comparator device. The use of
      the HBDA device will be evaluated for accuracy and identified risks. Additionally, measurable
      usability criteria for specific, critical steps will be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Evaluation of the % agreement of the Dip HBDA, tested by the lay user, as compared to a comparator device, tested by a professional user.
time frame: 11 months
measure: Evaluation of the Dip HBDA usability success rate, by potential lay users under actual use conditions
time frame: 11 months
arm group label: Dip Home-Based Dipstick Analyzer
arm group type: Experimental
description: The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm. Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user
intervention type: Device
intervention name: Experimental: Dip Home-Based Dipstick Analyzer
description: Dip Home-Based Dipstick Analyzer The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
arm group label: Dip Home-Based Dipstick Analyzer
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: Chronic Disease