xml: <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/NCT06027164</url>
    </required_header>
    <id_info>
      <org_study_id>ECHO-004</org_study_id>
      <nct_id>NCT06027164</nct_id>
    </id_info>
    <brief_title>Kosmos Trio and Ejection Fraction Pivotal Study</brief_title>
    <official_title>Kosmos Trio and Ejection Fraction Pivotal Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>EchoNous Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Revival Research Institute LLC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centaur Labs</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>EchoNous Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-group, observational study which will involve obtaining two echo scans of&#xD;
        recruited patients. All recruited patients will undergo echo scans by both novice users&#xD;
        (nurses) and experts (echo sonographers). Image quality between novices and experts as well&#xD;
        as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF&#xD;
        calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in&#xD;
        post-hoc Echo image analysis&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of Global Left Ventricular Function</measure>
      <time_frame>Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments</time_frame>
      <description>A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurses is of sufficient image quality to make a qualitative visual assessment of the Global Left Ventricular Function.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Left Ventricular Size</measure>
      <time_frame>Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments</time_frame>
      <description>A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of the Left Ventricular Size.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Non-Trivial Pericardial Effusion</measure>
      <time_frame>Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments</time_frame>
      <description>A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Non-Trivial Pericardial Effusion.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Right Ventricular Size</measure>
      <time_frame>Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments</time_frame>
      <description>A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Right Ventricle Size.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of Automatic Structure Labelling</measure>
      <time_frame>Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments</time_frame>
      <description>A panel of cardiologists will access and determine via a majority vote if the frame-level false discovery rate (FDR) of automated cardiac structure labeling as determined by expert cardiologists for scans acquired by cardiac sonographers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Manual vs. KOSMOS-EF for Sonographer Scans</measure>
      <time_frame>Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments</time_frame>
      <description>Measurements are computed for A4C and A2C scans acquired by sonographers . We will compare KOSMOS-EF LVEF calculation to LVEF calculated by a panel of cardiologists via a majority vote.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of Left Atrial Size</measure>
      <time_frame>Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments</time_frame>
      <description>A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Left Atrial Size.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">153</enrollment>
    <condition>Cardiac Disease</condition>
    <arm_group>
      <arm_group_label>Study Subjects</arm_group_label>
      <description>Ultrasound scans conducted by novice users and experts on this cohort.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Portable Ultrasound System</intervention_name>
      <description>EchoNous KOSMOS</description>
      <arm_group_label>Study Subjects</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients admitted to the Emergency Department Observation Unit (EDOU) will be eligible&#xD;
          for enrollment. Patients admitted to the EDOU often spend a prolonged amount of time in the&#xD;
          EDOU (often &gt; 24 hours) awaiting further testing, therapies, or specialist consultations,&#xD;
          thus recruiting from this pool of patients is most likely to allow for completion of study&#xD;
          procedures without impacting the course of their clinical care&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18-89 years of age&#xD;
  &#xD;
            -  Have capacity to provide written consent either themselves or via healthcare proxy as&#xD;
               determined by subjects' clinical care teams&#xD;
  &#xD;
            -  Have an anticipated timeline in the EDOU long enough to allow for completion of study&#xD;
               procedures without causing delay to subjects' usual clinical care&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Heart rate &gt; 110 beats per minute at the time of recruitment&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Prior chest surgery&#xD;
  &#xD;
            -  Chest wall deformities or injuries (i.e. wounds, infections, etc)&#xD;
  &#xD;
            -  Limited mobility precluding them from turning in bed independently&#xD;
  &#xD;
            -  Speak a primary language other than English or Spanish&#xD;
  &#xD;
            -  Vulnerable populations including: patients being evaluated for psychiatric crises,&#xD;
               incarcerated individuals&#xD;
  &#xD;
            -  Unwilling or unable to consent to study procedures&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Revival Research Institute LLC</name>
        <address>
          <city>Dearborn</city>
          <state>Michigan</state>
          <zip>48126</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>Heart Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027164
  org study id: ECHO-004
  nct id: NCT06027164
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This is a single-group, observational study which will involve obtaining two echo scans of
        recruited patients. All recruited patients will undergo echo scans by both novice users
        (nurses) and experts (echo sonographers). Image quality between novices and experts as well
        as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF
        calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in
        post-hoc Echo image analysis
  observational model: Cohort
  time perspective: Prospective
  measure: Assessment of Global Left Ventricular Function
  time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
  description: A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurses is of sufficient image quality to make a qualitative visual assessment of the Global Left Ventricular Function.
  measure: Assessment of Left Ventricular Size
  time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
  description: A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of the Left Ventricular Size.
  measure: Assessment of Non-Trivial Pericardial Effusion
  time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
  description: A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Non-Trivial Pericardial Effusion.
  measure: Assessment of Right Ventricular Size
  time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
  description: A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Right Ventricle Size.
  measure: Assessment of Automatic Structure Labelling
  time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
  description: A panel of cardiologists will access and determine via a majority vote if the frame-level false discovery rate (FDR) of automated cardiac structure labeling as determined by expert cardiologists for scans acquired by cardiac sonographers.
  measure: Manual vs. KOSMOS-EF for Sonographer Scans
  time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
  description: Measurements are computed for A4C and A2C scans acquired by sonographers . We will compare KOSMOS-EF LVEF calculation to LVEF calculated by a panel of cardiologists via a majority vote.
  measure: Assessment of Left Atrial Size
  time frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
  description: A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Left Atrial Size.
  arm group label: Study Subjects
  description: Ultrasound scans conducted by novice users and experts on this cohort.
  intervention type: Device
  intervention name: Portable Ultrasound System
  description: EchoNous KOSMOS
  arm group label: Study Subjects
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 89 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Heart Diseases