<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/NCT02973178</url>
  </required_header>
  <id_info>
    <org_study_id>FO-004</org_study_id>
    <nct_id>NCT02973178</nct_id>
  </id_info>
  <brief_title>Scanadu Urine Device Validation Study Protocol</brief_title>
  <official_title>Scanadu Urine Device Validation Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scanadu, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scanadu, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test Scanadu Urine Device for clinical performance and usability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are to:&#xD;
&#xD;
        -  Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands&#xD;
           of intended users as compared to: the visual read of chemical test strips performed by&#xD;
           lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).&#xD;
&#xD;
        -  Evaluate and validate the user-interface of the Scanadu Urine Device by the intended&#xD;
           users for human factors and user interface of the Scanadu Urine Device.&#xD;
&#xD;
        -  Evaluate the reproducibility in the hands of the lay-users after repeated testing of&#xD;
           samples with known test levels&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire</measure>
    <time_frame>Single visit in one day</time_frame>
    <description>Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Method Comparison: Conduct two tests by following iPhone app (self and patient samples), results in concordance with professional testers; achieve accuracy in different concentrations of six urine analytes each using approximately 20 samples per level.</measure>
    <time_frame>Single visit in one day</time_frame>
    <description>Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance.</measure>
    <time_frame>Single visit in one day</time_frame>
    <description>Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Urinary Tract Infections</condition>
  <condition>Proteinuria</condition>
  <condition>Ketone Urine</condition>
  <condition>Hematuria</condition>
  <condition>Glucose Intolerance</condition>
  <arm_group>
    <arm_group_label>Usability</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Method Comparison</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to:&#xD;
The visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396),&#xD;
Scanadu Urine Device tests performed by lab technicians.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reproducibility</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scanadu Urine Device</intervention_name>
    <description>Device to allow lay user to perform urinalysis test at home.</description>
    <arm_group_label>Method Comparison</arm_group_label>
    <arm_group_label>Reproducibility</arm_group_label>
    <arm_group_label>Usability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female and male&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  Pregnant or not pregnant&#xD;
&#xD;
          -  Must have experience using an Apple iPhone&#xD;
&#xD;
          -  Have no visual impairments&#xD;
&#xD;
          -  Able to hold Smart Phone horizontally in raised dominant hand&#xD;
&#xD;
          -  Must be able to read and understand English&#xD;
&#xD;
          -  Must provide Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a known history of a visual impairment that may affect reading and navigating the&#xD;
             Scanadu Urine app&#xD;
&#xD;
          -  Unable to void and collect urine specimen for testing&#xD;
&#xD;
          -  Unable to hold phone steady (horizontally) or has history of tremors or conditions&#xD;
             such as Parkinson's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jenny Li</last_name>
    <phone>650-567-6389</phone>
    <email>jenny.li@scanadu.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daya Ranamukhaarachchi</last_name>
    <phone>301-569-1213</phone>
    <email>daya@scanadu.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>West Coast Research, LLC</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tim Davis</last_name>
      <phone>925-413-1451</phone>
    </contact>
    <contact_backup>
      <last_name>Jenny Li</last_name>
      <phone>650-567-6389</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>West Coast Research, LLC</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94577</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 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>Urinary Tract Infections</mesh_term>
    <mesh_term>Proteinuria</mesh_term>
    <mesh_term>Hematuria</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 17, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>January 30, 2017</submitted>
    <returned>March 20, 2017</returned>
    <submitted>July 27, 2018</submitted>
    <returned>January 24, 2019</returned>
  </pending_results>
  <!-- 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/NCT02973178
org study id: FO-004
nct id: NCT02973178
lead sponsor: 
has dmc: No
This study will test Scanadu Urine Device for clinical performance and usability.
The objectives of this study are to:

        -  Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands
           of intended users as compared to: the visual read of chemical test strips performed by
           lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).

        -  Evaluate and validate the user-interface of the Scanadu Urine Device by the intended
           users for human factors and user interface of the Scanadu Urine Device.

        -  Evaluate the reproducibility in the hands of the lay-users after repeated testing of
           samples with known test levels
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Usability: % successful scans in three tests conducted by lay users in following the app on the iPhone and obtain user experience on questionnaire
time frame: Single visit in one day
description: Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.
measure: Method Comparison: Conduct two tests by following iPhone app (self and patient samples), results in concordance with professional testers; achieve accuracy in different concentrations of six urine analytes each using approximately 20 samples per level.
time frame: Single visit in one day
description: Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to: the visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396).
measure: Reproducibility: Lay user's ability to repeat a urine test nine times by following iPhone app and obtain nine results that are in concordance.
time frame: Single visit in one day
description: Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels
arm group label: Usability
arm group type: Other
description: Evaluate and validate the user-interface of the Scanadu Urine Device by the intended users for human factors and user interface of the Scanadu Urine Device.
arm group label: Method Comparison
arm group type: Active Comparator
description: Evaluate and validate the clinical performance of the Scanadu Urine Device in the hands of intended users as compared to:
The visual read of chemical test strips performed by lab technicians utilizing the Siemens Multistix® 10SG technology (K905396),
Scanadu Urine Device tests performed by lab technicians.
arm group label: Reproducibility
arm group type: Other
description: Evaluate the reproducibility in the hands of the lay-users after repeated testing of samples with known test levels.
intervention type: Device
intervention name: Scanadu Urine Device
description: Device to allow lay user to perform urinalysis test at home.
arm group label: Method Comparison
arm group label: Reproducibility
arm group label: Usability
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jenny Li
phone: 650-567-6389
email: jenny.li@scanadu.com
last name: Daya Ranamukhaarachchi
phone: 301-569-1213
email: daya@scanadu.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Completed
country: United States
responsible party type: Sponsor
mesh term: Urinary Tract Infections
mesh term: Proteinuria
mesh term: Hematuria
mesh term: Glucose Intolerance
sharing ipd: No
submitted: January 17, 2017
submission canceled: Unknown
submitted: January 30, 2017
returned: March 20, 2017
submitted: July 27, 2018
returned: January 24, 2019