<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/NCT03837769</url>
  </required_header>
  <id_info>
    <org_study_id>OBPM_ICU2018</org_study_id>
    <nct_id>NCT03837769</nct_id>
  </id_info>
  <brief_title>Validation of the Aktiia SA PulseWatch OBPM Device at the Wrist Against Invasive Blood Pressure Measurements</brief_title>
  <acronym>OBPM_ICU2018</acronym>
  <official_title>Single-center Intervention Study to Validate the Performance of the Aktiia SA PulseWatch Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Invasive Blood Pressure Measurements With Arterial Line</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Neuchatelois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aktiia SA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hopital Neuchatelois</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Single-centre intervention study to validate the performance of the Aktiia SA optical blood&#xD;
      pressure monitoring (OBPM) device at the wrist against invasive blood pressure measurements&#xD;
      with arterial line.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aktiia SA PulseWatch is an investigational device for the optical measurement of blood&#xD;
      pressure that uses only optical sensors at the wrist. HNE is interested in exploring the&#xD;
      potential of the device and technology (OBPM), and aims at benchmarking its performances&#xD;
      against gold standard measurements of blood pressure.&#xD;
&#xD;
      The goal of this study is thus to assess whether i) PulseWatch allows to capture blood&#xD;
      pressure variations, and ii) the measured blood pressure values remain stable in time.&#xD;
&#xD;
      The proposed study plans to include patients that are already scheduled for arterial&#xD;
      catheterization at HNE. For these patients, the study will only require the placement of the&#xD;
      safe optical device on the wrist to non-invasively record hemodynamic fluctuations.&#xD;
      Therefore, no additional risk for the patient is to be foreseen.&#xD;
&#xD;
      By demonstrating that the Aktiia SA OBPM technology is reliable, HNE aims to make one step&#xD;
      further in improving blood pressure monitoring in general, and in particular in advancing the&#xD;
      deployment of technologies that have the potential to be used in the ambulatory setting. The&#xD;
      diagnosis and treatment of hypertension are expected to largely benefit from these&#xD;
      advancements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 22, 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>Cuffless Blood Pressure performance</measure>
    <time_frame>4 Months</time_frame>
    <description>The evaluation of the accuracy (mean error and standard deviation of the error) of the non-invasive BP measurements at wrist with the PulseWatch against the reference gold-standard invasive blood pressure obtained by arterial line with respect to ISO 81060-2 (14) for two aspects: i) capturing the variations of the BP in short time and ii) maintaining the accurate stable measurements over extended periods of time.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Aktiia SA PulseWatch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aktiia OBPM PulseWatch wrist device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aktiia OBPM PulseWatch wrist device</intervention_name>
    <description>The optical signals at the wrist are recorded non-invasively. The BP measurements are further determined from these optical signals and are compared to the reference BP readings.</description>
    <arm_group_label>Aktiia SA PulseWatch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  No significant non-invasive systolic blood pressure difference between left arm and&#xD;
             right arm (difference &lt;20mmHg in systolic arterial pressure)&#xD;
&#xD;
          -  Patient requires continuous monitoring of diastolic and systolic blood pressure&#xD;
             continuously via a radial arterial line;&#xD;
&#xD;
          -  Patient information and informed consent is obtained following the procedures&#xD;
             described in CIP&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Arrythmias: tachycardia (resting heart rate &gt; 120/min) at time of study inclusion&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Psychomotor agitation&#xD;
&#xD;
          -  Significant bruises or trauma on forearm&#xD;
&#xD;
          -  Intravenous canula around the wrist with impossibility to place the device (Aktiia&#xD;
             OBPM PulseWatch) around the wrist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital neuchâtelois - Pourtalès</name>
      <address>
        <city>Neuchâtel</city>
        <zip>2000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.aktiia.com</url>
    <description>Aktiia SA website</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>May 31, 2019</last_update_submitted>
  <last_update_submitted_qc>May 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood Pressure</keyword>
  <keyword>OBPM</keyword>
  <keyword>Cuffless</keyword>
  <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/NCT03837769
org study id: OBPM_ICU2018
nct id: NCT03837769
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Single-centre intervention study to validate the performance of the Aktiia SA optical blood
      pressure monitoring (OBPM) device at the wrist against invasive blood pressure measurements
      with arterial line.
Aktiia SA PulseWatch is an investigational device for the optical measurement of blood
      pressure that uses only optical sensors at the wrist. HNE is interested in exploring the
      potential of the device and technology (OBPM), and aims at benchmarking its performances
      against gold standard measurements of blood pressure.

      The goal of this study is thus to assess whether i) PulseWatch allows to capture blood
      pressure variations, and ii) the measured blood pressure values remain stable in time.

      The proposed study plans to include patients that are already scheduled for arterial
      catheterization at HNE. For these patients, the study will only require the placement of the
      safe optical device on the wrist to non-invasively record hemodynamic fluctuations.
      Therefore, no additional risk for the patient is to be foreseen.

      By demonstrating that the Aktiia SA OBPM technology is reliable, HNE aims to make one step
      further in improving blood pressure monitoring in general, and in particular in advancing the
      deployment of technologies that have the potential to be used in the ambulatory setting. The
      diagnosis and treatment of hypertension are expected to largely benefit from these
      advancements.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Cuffless Blood Pressure performance
time frame: 4 Months
description: The evaluation of the accuracy (mean error and standard deviation of the error) of the non-invasive BP measurements at wrist with the PulseWatch against the reference gold-standard invasive blood pressure obtained by arterial line with respect to ISO 81060-2 (14) for two aspects: i) capturing the variations of the BP in short time and ii) maintaining the accurate stable measurements over extended periods of time.
arm group label: Aktiia SA PulseWatch
arm group type: Experimental
description: Aktiia OBPM PulseWatch wrist device
intervention type: Device
intervention name: Aktiia OBPM PulseWatch wrist device
description: The optical signals at the wrist are recorded non-invasively. The BP measurements are further determined from these optical signals and are compared to the reference BP readings.
arm group label: Aktiia SA PulseWatch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
url: http://www.aktiia.com
description: Aktiia SA website
responsible party type: Sponsor
sharing ipd: No