<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/NCT03774199</url>
  </required_header>
  <id_info>
    <org_study_id>17-023U1.1</org_study_id>
    <nct_id>NCT03774199</nct_id>
  </id_info>
  <brief_title>NightOwl Pulse Oximeter Calibration Study</brief_title>
  <acronym>NPOCS</acronym>
  <official_title>NightOwl Pulse Oximeter Calibration Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ectosense NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ectosense NV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Calibration of a software module that computes SpO2 based on photoplethysmography (PPG)&#xD;
      traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger&#xD;
      or the forehead.&#xD;
&#xD;
      The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular&#xD;
      requirements for basic safety and essential performance of pulse oximeter equipment (ISO&#xD;
      80601- 2-61:2011)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Anticipated">April 14, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 14, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A_rms determination</measure>
    <time_frame>Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed.</time_frame>
    <description>After calibration of the NightOwl SpO2 software module, the A_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pulse Oximeter Calibration</condition>
  <arm_group>
    <arm_group_label>Pulse oximeter calibration population</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NightOwl</intervention_name>
    <description>The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived</description>
    <arm_group_label>Pulse oximeter calibration population</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects (ASA 1 and ASA 2) upon signing the informed consent. (ASA : american&#xD;
             society of anesthesiologist's health score)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers or individuals exposed to high levels of carbon monoxide that result in&#xD;
             elevated carboxyhaemoglobin levels.&#xD;
&#xD;
          -  individuals subject to conditions that result in elevated levels of methaemoglobin.&#xD;
&#xD;
          -  individuals with arterial cannulation or hypoxia at FiO2 = 0,21&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Frederik Roger Massie, ir</last_name>
    <phone>474942710</phone>
    <phone_ext>+32</phone_ext>
    <email>frederik.massie@ectosense.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>CMC</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rafael De Jongh, MD PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03774199
org study id: 17-023U1.1
nct id: NCT03774199
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Calibration of a software module that computes SpO2 based on photoplethysmography (PPG)
      traces acquired by a reflectance-based pulse oximeter which can be placed on the index finger
      or the forehead.

      The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular
      requirements for basic safety and essential performance of pulse oximeter equipment (ISO
      80601- 2-61:2011)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: A_rms determination
time frame: Within 3 months after subject recruitment, the calibration and ARMS determination should have been performed.
description: After calibration of the NightOwl SpO2 software module, the A_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark.
arm group label: Pulse oximeter calibration population
arm group type: Other
intervention type: Device
intervention name: NightOwl
description: The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived
arm group label: Pulse oximeter calibration population
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frederik Roger Massie, ir
phone: 474942710
phone ext: +32
email: frederik.massie@ectosense.com
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
sharing ipd: No