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/NCT06002971</url>
    </required_header>
    <id_info>
      <org_study_id>230608-6</org_study_id>
      <nct_id>NCT06002971</nct_id>
    </id_info>
    <brief_title>CONNEQT Pulse Validation Study</brief_title>
    <official_title>Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mount Carmel Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AtCor Medical, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Mount Carmel Health System</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure&#xD;
        monitoring system for the measurement of blood pressure as compared to a gold standard,&#xD;
        auscultatory sphygmomanometer in a pregnant population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Clinical staff will review patient's medical record to determine eligibility. Following&#xD;
        informed consent, a brief medical history will be collected. Serial blood pressure&#xD;
        measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure&#xD;
        measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population&#xD;
        according to ISO protocol 81060-2.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.</measure>
      <time_frame>Up to 60 minutes</time_frame>
      <description>Paired means and standard deviations of both systolic and diastolic blood pressure readings will be analyzed according to section 5.2.4.1.2 of ISO 81060-2 protocol.</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Pregnancy Related</condition>
    <condition>Pre-Eclampsia</condition>
    <condition>Gestational Hypertension</condition>
    <arm_group>
      <arm_group_label>Normotensive</arm_group_label>
      <description>Normotensive pregnant patients beyond the first trimester with systolic blood pressure &lt;140 mmHg and diastolic blood pressure &lt;90 mmHg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hypertensive</arm_group_label>
      <description>Hypertensive pregnant patients beyond the first trimester:&#xD;
  i) without proteinuria &gt;300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pre-Eclampsia</arm_group_label>
      <description>Pre-eclampsia patients beyond the first trimester:&#xD;
  i) with proteinuria &gt;300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Blood pressure measurement</intervention_name>
      <description>Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.</description>
      <arm_group_label>Hypertensive</arm_group_label>
      <arm_group_label>Normotensive</arm_group_label>
      <arm_group_label>Pre-Eclampsia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant patients 18 years or older and beyond the first trimester, as defined as 12&#xD;
          completed weeks of gestation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          All Groups:&#xD;
  &#xD;
            1. Able to provide informed consent&#xD;
  &#xD;
            2. Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)&#xD;
  &#xD;
            3. 18 years of age, or older&#xD;
  &#xD;
          Normotensive:&#xD;
  &#xD;
          1. Systolic blood pressure &lt;140 mmHg (18,66 kPa) and diastolic blood pressure &lt;90 mmHg (12&#xD;
          kPa)&#xD;
  &#xD;
          Hypertensive:&#xD;
  &#xD;
            1. Without proteinuria &gt;300 mg in 24 h; and&#xD;
  &#xD;
            2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90&#xD;
               mmHg (12 kPa)&#xD;
  &#xD;
          Pre-Eclampsia:&#xD;
  &#xD;
            1. With proteinuria &gt;300 mg in 24 h; and&#xD;
  &#xD;
            2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90&#xD;
               mmHg (12,00 kPa)&#xD;
        </textblock>
      </criteria>
      <gender>Female</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>Robin L Driver, BS</last_name>
      <phone>(614) 620-6590</phone>
      <email>rdriver@mchs.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cameron Rink, PhD</last_name>
      <phone>(614) 546-4518</phone>
      <email>cameron.rink@mchs.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mount Carmel Health System</investigator_affiliation>
      <investigator_full_name>Robin Driver</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Eclampsia</mesh_term>
      <mesh_term>Pre-Eclampsia</mesh_term>
      <mesh_term>Hypertension, Pregnancy-Induced</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/NCT06002971
  org study id: 230608-6
  nct id: NCT06002971
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure
        monitoring system for the measurement of blood pressure as compared to a gold standard,
        auscultatory sphygmomanometer in a pregnant population.
  Clinical staff will review patient's medical record to determine eligibility. Following
        informed consent, a brief medical history will be collected. Serial blood pressure
        measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure
        measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population
        according to ISO protocol 81060-2.
  observational model: Cohort
  time perspective: Prospective
  measure: Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.
  time frame: Up to 60 minutes
  description: Paired means and standard deviations of both systolic and diastolic blood pressure readings will be analyzed according to section 5.2.4.1.2 of ISO 81060-2 protocol.
  arm group label: Normotensive
  description: Normotensive pregnant patients beyond the first trimester with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg
  arm group label: Hypertensive
  description: Hypertensive pregnant patients beyond the first trimester:
  i) without proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg
  arm group label: Pre-Eclampsia
  description: Pre-eclampsia patients beyond the first trimester:
  i) with proteinuria >300 mg in 24 h; and ii) with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥ 90 mmHg
  intervention type: Device
  intervention name: Blood pressure measurement
  description: Serial blood pressure measurements to compare reference auscultatory sphygmomanometer to CONNEQT Pulse according to ISO 81060-2.
  arm group label: Hypertensive
  arm group label: Normotensive
  arm group label: Pre-Eclampsia
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Robin L Driver, BS
  phone: (614) 620-6590
  email: rdriver@mchs.com
  last name: Cameron Rink, PhD
  phone: (614) 546-4518
  email: cameron.rink@mchs.com
  responsible party type: Principal Investigator
  investigator affiliation: Mount Carmel Health System
  investigator full name: Robin Driver
  investigator title: Principal Investigator
  mesh term: Eclampsia
  mesh term: Pre-Eclampsia
  mesh term: Hypertension, Pregnancy-Induced