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/NCT05962905</url>
    </required_header>
    <id_info>
      <org_study_id>MDT23002INCATH</org_study_id>
      <nct_id>NCT05962905</nct_id>
    </id_info>
    <brief_title>Accuracy Performance Verification of the INVOS™ System in Pediatrics</brief_title>
    <acronym>INCATH</acronym>
    <official_title>Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medtronic - MITG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medtronic - MITG</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <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>
        Prospective, observational, multi-center trial designed to capture calibration and&#xD;
        performance evaluation data with the INVOS™ system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to verify INVOS™ cerebral oximetry system performance in&#xD;
        pediatric and infant patients by comparing regional oxygen saturation (rSO2) values to&#xD;
        reference blood oxygen saturation measurements obtained through internal jugular vein and&#xD;
        arterial blood convenience sampling according to International Organization on Standards&#xD;
        (ISO) 80601-2-85:2021.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</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>Accuracy of the root mean square</measure>
      <time_frame>At the point of blood sampling during cardiac catheterization procedure</time_frame>
      <description>root mean square of the difference in regional oxygen saturation (rSO2) as measured by the INVOS and field saturation (fSO2) as measured by blood sampling</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cerebral Oxygenation</condition>
    <condition>Pediatric ALL</condition>
    <arm_group>
      <arm_group_label>Pediatric</arm_group_label>
      <description>Subjects meeting inclusion criteria weighing between 4 and 40 kg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Infant</arm_group_label>
      <description>Subjects meeting inclusion criteria weighing under 40 kg</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood sample</intervention_name>
      <description>During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization</description>
      <arm_group_label>Infant</arm_group_label>
      <arm_group_label>Pediatric</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>INVOS monitoring</intervention_name>
      <description>During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry.</description>
      <arm_group_label>Infant</arm_group_label>
      <arm_group_label>Pediatric</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric patients (under 21) weighing under 40 kg scheduled for a diagnostic or&#xD;
          interventional cardiac catheterization procedure with general anesthesia or sedation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Under 21 years of age&#xD;
  &#xD;
            2. Meets weight requirement for sensors under study&#xD;
  &#xD;
            3. Scheduled for a diagnostic or interventional cardiac catheterization procedure with&#xD;
               general anesthesia or sedation&#xD;
  &#xD;
            4. Arterial and venous access as part of the planned catheterization procedure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]&#xD;
  &#xD;
            2. A skin condition at the sensor site (e.g., rash, abrasion, laceration)&#xD;
  &#xD;
            3. Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead&#xD;
               application of the sensor&#xD;
  &#xD;
            4. A known structural brain lesion beneath the sensor&#xD;
  &#xD;
            5. Known hemoglobinopathy&#xD;
  &#xD;
            6. Inability to lie supine with neutral neck position during catheterization&#xD;
  &#xD;
            7. Cerebrovascular disease&#xD;
  &#xD;
            8. An emergent, life threatening condition impacting study conduct&#xD;
  &#xD;
            9. Unwillingness or inability to sign informed consent (IC) or assent by the&#xD;
               parents/guardians of child&#xD;
  &#xD;
           10. Currently receiving phototherapy for bilirubin&#xD;
  &#xD;
           11. Arterial or venous anatomy that would preclude obtaining an accurate paired sample&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Ami R Stuart, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Principal Clinical Research Specialist</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Monika Deshpande</last_name>
      <phone>3033052632</phone>
      <email>monika.s.deshpande@medtronic.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>cerebral oximetry</keyword>
    <keyword>pediatric</keyword>
    <keyword>infant</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05962905
  org study id: MDT23002INCATH
  nct id: NCT05962905
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Prospective, observational, multi-center trial designed to capture calibration and
        performance evaluation data with the INVOS™ system.
  The purpose of this study is to verify INVOS™ cerebral oximetry system performance in
        pediatric and infant patients by comparing regional oxygen saturation (rSO2) values to
        reference blood oxygen saturation measurements obtained through internal jugular vein and
        arterial blood convenience sampling according to International Organization on Standards
        (ISO) 80601-2-85:2021.
  observational model: Cohort
  time perspective: Prospective
  measure: Accuracy of the root mean square
  time frame: At the point of blood sampling during cardiac catheterization procedure
  description: root mean square of the difference in regional oxygen saturation (rSO2) as measured by the INVOS and field saturation (fSO2) as measured by blood sampling
  arm group label: Pediatric
  description: Subjects meeting inclusion criteria weighing between 4 and 40 kg
  arm group label: Infant
  description: Subjects meeting inclusion criteria weighing under 40 kg
  intervention type: Other
  intervention name: Blood sample
  description: During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization
  arm group label: Infant
  arm group label: Pediatric
  intervention type: Device
  intervention name: INVOS monitoring
  description: During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry.
  arm group label: Infant
  arm group label: Pediatric
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 21 Years
  last name: Ami R Stuart, PhD
  role: Study Director
  affiliation: Principal Clinical Research Specialist
  last name: Monika Deshpande
  phone: 3033052632
  email: monika.s.deshpande@medtronic.com
  responsible party type: Sponsor
  sharing ipd: No