<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/NCT03800069</url>
  </required_header>
  <id_info>
    <org_study_id>829476</org_study_id>
    <nct_id>NCT03800069</nct_id>
  </id_info>
  <brief_title>Validation of Point of Care Liver Function Tests</brief_title>
  <official_title>Biomedical Device Trial of Validation of Point of Care Liver Function Tests</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Group K Diagnostics Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</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>
      This study is testing the accuracy of a point of care device that tests liver function within&#xD;
      20 minutes. The target population will be any adult who had liver function tests ordered and&#xD;
      to be drawn on the same day as enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and&#xD;
      high cost. Sometimes patients do not make it to laboratory testing if a lab is not available&#xD;
      on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.&#xD;
&#xD;
      Group K developed a paper microfluidic platform with an accompanying mobile application(app).&#xD;
      The paper microfluidic device is a simple, inexpensive wax backed device with three testing&#xD;
      areas. These areas have a mix of dried proprietary reagents that when combined with a&#xD;
      patients drop of blood, or in the future, saliva or urine, will produce results in a color&#xD;
      change. An app is then used to interpret the color change and output results to a doctor. The&#xD;
      target population is adults who have an indication to collect a liver function panel that&#xD;
      will be drawn on the same day as their clinic visit or during their inpatient hospital&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    scheduling complexities&#xD;
  </why_stopped>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Regression curve and correlation coefficient</measure>
    <time_frame>1 year</time_frame>
    <description>Each data point will represent one observation or one test run. The investigators will use regression methods to determine the linear relationship between standard lab results and Group K diagnostic's device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The consistent accuracy of the diagnostic device</measure>
    <time_frame>1 year</time_frame>
    <description>Lowest level frequency of detection must be detected 90% of the time. This will become the functional lower limit. The same with the highest level of frequency.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Healthy</condition>
  <condition>Cirrhosis, Liver</condition>
  <condition>Fibrosis</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <description>A finger stick sample is collected and tested on the study device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group K Diagnostic point of care device</intervention_name>
    <description>Arm 1 will have a finger prick sample collected to test the ability of Group K Diagnostic point of care device and app to identify liver function values.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population will be selected from inpatient and clinic setting at The Hospital of the&#xD;
        University of Pennsylvania.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a liver function testing for the required 6 tests completed (Alanine&#xD;
             Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP),&#xD;
             albumin, bilirubin, and total protein)&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inadequate blood sample obtained from finger stick&#xD;
&#xD;
          -  Inconclusive liver function testing&#xD;
&#xD;
          -  Not all 6 liver tests completed on the same sample&#xD;
&#xD;
          -  Liver tests not drawn for normal method at same time as finger stick.&#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_official>
    <last_name>Vandana Khungar, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director of Inpatient Hepatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital of the University of Pennslyvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 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>Liver Diseases</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03800069/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03800069/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03800069
org study id: 829476
nct id: NCT03800069
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is testing the accuracy of a point of care device that tests liver function within
      20 minutes. The target population will be any adult who had liver function tests ordered and
      to be drawn on the same day as enrollment.
Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and
      high cost. Sometimes patients do not make it to laboratory testing if a lab is not available
      on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.

      Group K developed a paper microfluidic platform with an accompanying mobile application(app).
      The paper microfluidic device is a simple, inexpensive wax backed device with three testing
      areas. These areas have a mix of dried proprietary reagents that when combined with a
      patients drop of blood, or in the future, saliva or urine, will produce results in a color
      change. An app is then used to interpret the color change and output results to a doctor. The
      target population is adults who have an indication to collect a liver function panel that
      will be drawn on the same day as their clinic visit or during their inpatient hospital
observational model: Cohort
time perspective: Cross-Sectional
measure: Regression curve and correlation coefficient
time frame: 1 year
description: Each data point will represent one observation or one test run. The investigators will use regression methods to determine the linear relationship between standard lab results and Group K diagnostic's device.
measure: The consistent accuracy of the diagnostic device
time frame: 1 year
description: Lowest level frequency of detection must be detected 90% of the time. This will become the functional lower limit. The same with the highest level of frequency.
arm group label: Arm 1
description: A finger stick sample is collected and tested on the study device.
intervention type: Device
intervention name: Group K Diagnostic point of care device
description: Arm 1 will have a finger prick sample collected to test the ability of Group K Diagnostic point of care device and app to identify liver function values.
arm group label: Arm 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vandana Khungar, MD, MSc
role: Principal Investigator
affiliation: Director of Inpatient Hepatology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Liver Cirrhosis
sharing ipd: No
provided document: 
provided document: 