<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/NCT02975050</url>
  </required_header>
  <id_info>
    <org_study_id>2016-KM-001</org_study_id>
    <nct_id>NCT02975050</nct_id>
  </id_info>
  <brief_title>Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)</brief_title>
  <acronym>ViVUS</acronym>
  <official_title>Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyma Medical Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyma Medical Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study has the following objective:&#xD;
&#xD;
      • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration&#xD;
      Rate (RR), Posture and Activity in healthy human subjects.&#xD;
&#xD;
      The μ-Cor validation will be demonstrated at two body locations:&#xD;
&#xD;
        1. Side location (below left armpit) for study arm 1, and&#xD;
&#xD;
        2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will&#xD;
           be used to support the validation of the study device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has the following objective:&#xD;
&#xD;
      • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration&#xD;
      Rate (RR), Posture and Activity in healthy human subjects.&#xD;
&#xD;
      The μ-Cor validation will be demonstrated at two body locations:&#xD;
&#xD;
        1. Side location (below left armpit) for study arm 1, and&#xD;
&#xD;
        2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will&#xD;
           be used to support the validation of the study device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2016</start_date>
  <completion_date type="Actual">January 19, 2017</completion_date>
  <primary_completion_date type="Actual">January 19, 2017</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>Respiratory rate</measure>
    <time_frame>Immediately</time_frame>
    <description>The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Posture</measure>
    <time_frame>Immediately</time_frame>
    <description>90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activity</measure>
    <time_frame>Immediately</time_frame>
    <description>μCor output is provided as &quot;active&quot; and &quot;not active&quot;. 90% correct classification of activity will be required of recordings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>Immediately</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG</measure>
    <time_frame>Immediately</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Health Volunteer Validation Study</condition>
  <arm_group>
    <arm_group_label>Side location</arm_group_label>
    <description>u-Cor device will be applied on side location</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Front location</arm_group_label>
    <description>u-Cor device will be applied on front location</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Location</intervention_name>
    <arm_group_label>Front location</arm_group_label>
    <arm_group_label>Side location</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is at least 21 years of age or older.&#xD;
&#xD;
          -  Subject is willing and able to sign the Informed Consent Form.&#xD;
&#xD;
          -  Subject is healthy, able and willing to complete all the preparation steps and study&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Female subject with a known pregnancy or unsure about pregnancy status.&#xD;
&#xD;
          -  Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic&#xD;
             based adhesive.&#xD;
&#xD;
          -  Subjects with skin breakdown in areas where device placement is required.&#xD;
&#xD;
          -  Subjects with chronic lung disease or asthma.&#xD;
&#xD;
          -  Subjects with a history of cardiovascular diseases.&#xD;
&#xD;
          -  Subjects who are diabetic.&#xD;
&#xD;
          -  Subjects living with kidney failure or dialysis.&#xD;
&#xD;
          -  Subjects with a history of liver failure.&#xD;
&#xD;
          -  Subjects with any known malignancy (i.e. cancer patients).&#xD;
&#xD;
          -  Subjects with implanted devices in the thoracic region&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 11, 2022</submitted>
    <returned>August 29, 2023</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/NCT02975050
org study id: 2016-KM-001
nct id: NCT02975050
lead sponsor: 
has dmc: No
This study has the following objective:

      • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration
      Rate (RR), Posture and Activity in healthy human subjects.

      The μ-Cor validation will be demonstrated at two body locations:

        1. Side location (below left armpit) for study arm 1, and

        2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will
           be used to support the validation of the study device.
This study has the following objective:

      • To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration
      Rate (RR), Posture and Activity in healthy human subjects.

      The μ-Cor validation will be demonstrated at two body locations:

        1. Side location (below left armpit) for study arm 1, and

        2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will
           be used to support the validation of the study device.
observational model: Cohort
time perspective: Prospective
measure: Respiratory rate
time frame: Immediately
description: The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).
measure: Posture
time frame: Immediately
description: 90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position
measure: Activity
time frame: Immediately
description: μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.
measure: Heart Rate
time frame: Immediately
measure: ECG
time frame: Immediately
arm group label: Side location
description: u-Cor device will be applied on side location
arm group label: Front location
description: u-Cor device will be applied on front location
intervention type: Other
intervention name: Location
arm group label: Front location
arm group label: Side location
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No
submitted: October 11, 2022
returned: August 29, 2023