<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/NCT04409561</url>
  </required_header>
  <id_info>
    <org_study_id>AB-PSP-003</org_study_id>
    <nct_id>NCT04409561</nct_id>
  </id_info>
  <brief_title>Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population</brief_title>
  <official_title>A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abionic SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Biomedical Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ocean State Clinical Coordinating Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abionic SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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>
      This is a single center, prospective, biomarker-result-blinded observational study evaluating&#xD;
      immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE&#xD;
      device with the PSP assay on generally healthy adults representative of the US population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2021</start_date>
  <completion_date type="Actual">January 15, 2022</completion_date>
  <primary_completion_date type="Actual">November 15, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Determination of reference range interval of PSP</measure>
    <time_frame>Day 1</time_frame>
    <description>To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Collect medical data of healthy volunteer</measure>
    <time_frame>Day 1</time_frame>
    <description>To collect medical data from the 150 study participants using a volunteer questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obtain well characterised samples library to be used for future tests development</measure>
    <time_frame>Day 1</time_frame>
    <description>Whole blood collection from 150 healthy subject to be used for future tests development.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Interventions</arm_group_label>
    <description>This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood collection</intervention_name>
    <description>9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits</description>
    <arm_group_label>Interventions</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous&#xD;
      whole blood will be collected, processed in plasma and stored until the shipment to the&#xD;
      sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        150 generally healthy adults. This patient pool shall be representative of the US&#xD;
        population in term of the relative proportion of race/ethnicities. In addition, the&#xD;
        population shall be enriched with patients above 60 year old as the target population of&#xD;
        the PSP test is mostly the elderly.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, aged ≥ 18 years.&#xD;
&#xD;
          2. Apparently healthy as determined by a subject questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Current diagnosis, or history, of any underlying major medical condition determined by&#xD;
        the investigator, including but not limited to:&#xD;
&#xD;
          1. Heart disease&#xD;
&#xD;
          2. Stroke&#xD;
&#xD;
          3. Renal disease&#xD;
&#xD;
          4. Liver disease&#xD;
&#xD;
          5. Pancreatic disease&#xD;
&#xD;
          6. Chronic obstructive pulmonary disorder&#xD;
&#xD;
          7. Bleeding disorders&#xD;
&#xD;
          8. Hypercalcitoninemia&#xD;
&#xD;
          9. HIV AIDS&#xD;
&#xD;
         10. Receiving antibiotic therapy&#xD;
&#xD;
         11. Suspected infection&#xD;
&#xD;
         12. Immunosuppression&#xD;
&#xD;
             2) Underwent procedures related to sepsis, or diagnosed with sepsis, within the last&#xD;
             12 months.&#xD;
&#xD;
             3) Current diagnosis of uncontrolled hypertension, hypotension, or diabetes.&#xD;
&#xD;
             4) Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that&#xD;
             required antimicrobial treatment.&#xD;
&#xD;
             5 )Experienced severe trauma, surgery, cardiac shock, or severe burn within the&#xD;
             previous 3 months requiring medical care.&#xD;
&#xD;
             6) Current diagnosis of cancer within the last 12 months.&#xD;
&#xD;
             7) Received immunotherapy to stimulate or inhibit cytokines within the last 12 months.&#xD;
&#xD;
             8) Hospitalization for more than 24 hours within the last 3 months.&#xD;
&#xD;
             9) Reported as currently pregnant or nursing a child&#xD;
&#xD;
             10) Unable or unwilling to provide the required blood sample for testing.&#xD;
&#xD;
             11) Any other criteria that, in the opinion of the investigator, would render the&#xD;
             participant unsuitable for inclusion in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Mercy Health St. Vincent</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>Pancreatic Stone Protein</keyword>
  <keyword>Immunoassay</keyword>
  <keyword>Abionic</keyword>
  <keyword>Healthy population</keyword>
  <keyword>Point-of-care device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Shock, Septic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04409561
org study id: AB-PSP-003
nct id: NCT04409561
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This is a single center, prospective, biomarker-result-blinded observational study evaluating
      immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE
      device with the PSP assay on generally healthy adults representative of the US population.
observational model: Cohort
time perspective: Prospective
measure: Determination of reference range interval of PSP
time frame: Day 1
description: To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.
measure: Collect medical data of healthy volunteer
time frame: Day 1
description: To collect medical data from the 150 study participants using a volunteer questionnaire
measure: Obtain well characterised samples library to be used for future tests development
time frame: Day 1
description: Whole blood collection from 150 healthy subject to be used for future tests development.
arm group label: Interventions
description: This patient pool shall be representative of the US population in term of the relative proportion of race/ethnicities. In addition, the population shall be enriched with patients above 60 year old as the target population of the PSP test is mostly the elderly.
intervention type: Device
intervention name: Blood collection
description: 9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits
arm group label: Interventions
9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous
      whole blood will be collected, processed in plasma and stored until the shipment to the
      sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Shock, Septic
sharing ipd: Undecided