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/NCT05976425</url>
    </required_header>
    <id_info>
      <org_study_id>60106449</org_study_id>
      <nct_id>NCT05976425</nct_id>
    </id_info>
    <brief_title>ModPG3 Neo-Infant ISO 81060</brief_title>
    <official_title>ModPG3 Neonate and Infant AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baxter Healthcare Corporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Baxter Healthcare Corporation</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Automated blood pressure cuff measurements taken by an &quot;oscillometric device&quot; is the standard&#xD;
        in numerous medical settings today.&#xD;
  &#xD;
        Studies show that oscillometric devices using algorithms are more accurate and consistent&#xD;
        than devices using other non-invasive measuring techniques, especially in critical cases.&#xD;
  &#xD;
        SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so&#xD;
        during deflation.&#xD;
  &#xD;
        The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and&#xD;
        Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020&#xD;
        Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated&#xD;
        measurement type&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Compliance of the ModPG3 blood pressure (BP) readings with ISO Requirements</measure>
      <time_frame>Day 1 (up to one hour)</time_frame>
      <description>Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Blood Pressure</condition>
    <arm_group>
      <arm_group_label>Blood pressure readings</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Using the data acquisition software provided, a reading for the subject will be started. The tool will automatically record the pre invasive blood pressure readings, then take the NIBP measurement with the device under test, and it will follow up with a post invasive blood pressure reading.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ModPG3 Investigational Device</intervention_name>
      <description>Connex Vital Sign Monitor with ModPG3&#xD;
  Laptop&#xD;
  Data Collection Software&#xD;
  USB cable&#xD;
  Power strip&#xD;
  Welch Allyn FlexiPort Disposable Blood Pressure Cuffs</description>
      <arm_group_label>Blood pressure readings</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Invasive Reference Equipment</intervention_name>
      <description>Surveyor S12/S19&#xD;
  Hill-Rom ICU Medical data collection cable DIR 60119852&#xD;
  Hill-Rom Edwards data collection cable DIR 60119853</description>
      <arm_group_label>Blood pressure readings</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          1. Inclusion Criteria&#xD;
  &#xD;
                 -  Meets the neonatal or infant (less than 3 years of age) subject population.&#xD;
  &#xD;
                 -  The neonate and infant subjects will already have an indwelling intra-arterial&#xD;
                    line.&#xD;
  &#xD;
                 -  Subject's legally authorized representative must consent for the subject to&#xD;
                    participate.&#xD;
  &#xD;
                 -  Subject's legally authorized representative must be able to read, write, speak in&#xD;
                    English and/or Italian.&#xD;
  &#xD;
                 -  Subject must have an arm circumference in the range of 3.3-15.0 cm.&#xD;
  &#xD;
                 -  Subject must be able to have blood pressures taken on the upper extremity closest&#xD;
                    to the arterial line&#xD;
  &#xD;
                 -  The subject has one upper arm that is free of indwelling catheters or IV lines,&#xD;
                    shunts, oximetry sensors, dressings, etc. for attachment of a NIBP cuff.&#xD;
  &#xD;
            2. Exclusion Criteria&#xD;
  &#xD;
                 -  Lack of Informed consent.&#xD;
  &#xD;
                 -  Subjects with deformities or abnormalities that may prevent proper application of&#xD;
                    the device under test.&#xD;
  &#xD;
                 -  Subject is evaluated by the investigator or clinician and found to be medically&#xD;
                    unsuitable for participation in this study.&#xD;
  &#xD;
                 -  Subjects with known heart dysrhythmias or arrhythmias during the measurement&#xD;
                    period.&#xD;
  &#xD;
                 -  Subjects with compromised circulation or peripheral vascular disease.&#xD;
  &#xD;
                 -  Subjects who have had surgery or have shunts or implants in the upper extremity&#xD;
                    being tested.&#xD;
  &#xD;
                 -  Those who have a heart rate that is irregular for any reason other than normal&#xD;
                    fluctuations in the R-to-R interval associated with respiration.&#xD;
  &#xD;
                 -  Hospital System Pre-Screening NIBP: those who have a systolic and/or diastolic&#xD;
                    blood pressures difference &gt; 12 mmHg between the hospital intra-arterial&#xD;
                    measurement and the hospital blood pressure cuff/automated vital signs monitor&#xD;
                    are excluded. The device under test cannot be used for this reading.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>3 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Baxter Clinical Trials Disclosure Call Center</last_name>
      <phone>(224) 948-7359</phone>
      <email>Global_CORP_ClinicalTrialsDisclosure@baxter.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>haring of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Upon approval of a legitimate research request.</ipd_time_frame>
      <ipd_access_criteria>Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.</ipd_access_criteria>
      <ipd_url>https://www.baxter.com/clinical-trial-transparency-and-data-sharing-policy</ipd_url>
    </patient_data>
    <!-- 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/NCT05976425
  org study id: 60106449
  nct id: NCT05976425
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: Yes
  Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard
        in numerous medical settings today.
  
        Studies show that oscillometric devices using algorithms are more accurate and consistent
        than devices using other non-invasive measuring techniques, especially in critical cases.
  
        SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so
        during deflation.
  
        The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and
        Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020
        Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated
        measurement type
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Compliance of the ModPG3 blood pressure (BP) readings with ISO Requirements
  time frame: Day 1 (up to one hour)
  description: Data shall be analyzed according to the formulas called out in section 6.2.6 of ISO 81060-2:2018/Amd 1:2020.
  arm group label: Blood pressure readings
  arm group type: Experimental
  description: Using the data acquisition software provided, a reading for the subject will be started. The tool will automatically record the pre invasive blood pressure readings, then take the NIBP measurement with the device under test, and it will follow up with a post invasive blood pressure reading.
  intervention type: Device
  intervention name: ModPG3 Investigational Device
  description: Connex Vital Sign Monitor with ModPG3
  Laptop
  Data Collection Software
  USB cable
  Power strip
  Welch Allyn FlexiPort Disposable Blood Pressure Cuffs
  arm group label: Blood pressure readings
  intervention type: Device
  intervention name: Invasive Reference Equipment
  description: Surveyor S12/S19
  Hill-Rom ICU Medical data collection cable DIR 60119852
  Hill-Rom Edwards data collection cable DIR 60119853
  arm group label: Blood pressure readings
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 3 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Baxter Clinical Trials Disclosure Call Center
  phone: (224) 948-7359
  email: Global_CORP_ClinicalTrialsDisclosure@baxter.com
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: haring of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Upon approval of a legitimate research request.
  ipd access criteria: Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.
  ipd url: https://www.baxter.com/clinical-trial-transparency-and-data-sharing-policy