<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/NCT04456179</url>
  </required_header>
  <id_info>
    <org_study_id>PR2020-363</org_study_id>
    <nct_id>NCT04456179</nct_id>
  </id_info>
  <brief_title>Continuous Non-Invasive Blood Pressure System Data Collection in Comparison to Invasive Radial Arterial Pressure</brief_title>
  <official_title>Evaluation of Sensifree's PPG Based Continuous &amp; Non-Invasive Blood Pressure Monitoring System in Comparison to Invasive Radial Arterial Line</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sensifree Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sensifree Ltd.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate methods to modify blood pressure in humans and&#xD;
      measure the effectiveness of such methods. A secondary outcome is to evaluate the performance&#xD;
      of an investigational continuous non-invasive blood pressure (cNIBP) device created by&#xD;
      Sensifree. The tests will per performed in non-hospitalized subjects under varied controlled&#xD;
      conditions that include resting blood pressure and non-pharmacologically induced blood&#xD;
      pressure changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On a first visit a screening procedure to verify inclusion / exclusion criteria are met will&#xD;
      be conducted. On the primary procedure visit, data collection will begin with the subjects&#xD;
      having the investigational device, ECG sensors, and 1 or more pulse oximetry sensors placed&#xD;
      on them for data collection and to monitor their safety for the duration of the study. A&#xD;
      physician will place an arterial line in the radial artery. The Sensifree cNIBP system will&#xD;
      be calibrated with an oscillometric and/or auscultatory blood pressure cuff measurement taken&#xD;
      on the arm opposite the arterial line.&#xD;
&#xD;
      A series of blood pressure changes will be induced, including various combinations of&#xD;
      methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 3, 2020</start_date>
  <completion_date type="Actual">February 6, 2020</completion_date>
  <primary_completion_date type="Actual">February 6, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans</measure>
    <time_frame>3-4 hours per subject</time_frame>
    <description>Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg):&#xD;
Hand grip&#xD;
Weight lifting&#xD;
Leg static effort</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device</measure>
    <time_frame>3-4 hours per subject</time_frame>
    <description>Comparison of BP values (Systolic, Diastolic, MAP) that are calculated by the investigational device to the BP values measured by the arterial line during isometric effort comprising a combination of the following isometric efforts on a subject's blood pressure:&#xD;
Hand grip&#xD;
Weight lifting&#xD;
Leg static effort</description>
  </secondary_outcome>
  <enrollment type="Actual">6</enrollment>
  <condition>Blood Pressure Measurement</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor</intervention_name>
    <description>PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arrow® arterial catheterization kit (Teleflex)</intervention_name>
    <description>Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have the ability to understand and provide written informed consent&#xD;
&#xD;
          -  Subject must be willing and able to comply with study procedures and duration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with a BMI over 39&#xD;
&#xD;
          -  Deformities or abnormalities that may prevent proper application of the device under&#xD;
             test&#xD;
&#xD;
          -  Lateral difference in blood pressure greater than 5mmHg diastolic and 9mmHg systolic&#xD;
&#xD;
          -  Tachycardia or resting heart rate less than 45 bpm&#xD;
&#xD;
          -  Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine&#xD;
             pregnancy test unless the subject is known to be not of child-bearing potential)&#xD;
&#xD;
          -  Subjects with known respiratory conditions such as: (self-reported)&#xD;
&#xD;
               -  uncontrolled / severe asthma,&#xD;
&#xD;
               -  flu,&#xD;
&#xD;
               -  pneumonia / bronchitis,&#xD;
&#xD;
               -  shortness of breath / respiratory distress,&#xD;
&#xD;
               -  respiratory or lung surgery,&#xD;
&#xD;
               -  emphysema, COPD, lung disease&#xD;
&#xD;
          -  Subjects with known heart or cardiovascular conditions such as: (self-reported, except&#xD;
             for blood pressure and ECG review)&#xD;
&#xD;
               -  have had cardiovascular surgery&#xD;
&#xD;
               -  have cardiac pacemakers and/or automatic internal cardio-defibrillator&#xD;
&#xD;
               -  Chest pain (angina)&#xD;
&#xD;
               -  Abnormal pulse pressure&#xD;
&#xD;
               -  previous heart attack&#xD;
&#xD;
               -  blocked artery&#xD;
&#xD;
               -  unexplained shortness of breath&#xD;
&#xD;
               -  congestive heart failure (CHF)&#xD;
&#xD;
               -  history of stroke&#xD;
&#xD;
               -  transient ischemic attack&#xD;
&#xD;
               -  carotid artery disease&#xD;
&#xD;
               -  myocardial ischemia&#xD;
&#xD;
               -  myocardial infarction&#xD;
&#xD;
               -  cardiomyopathy&#xD;
&#xD;
               -  Pulsus Paradoxus&#xD;
&#xD;
          -  Self-reported health conditions as identified in the Health Assessment Form&#xD;
             (self-reported)&#xD;
&#xD;
               -  diabetes,&#xD;
&#xD;
               -  uncontrolled thyroid disease,&#xD;
&#xD;
               -  kidney disease / chronic renal impairment,&#xD;
&#xD;
               -  history of seizures (except childhood febrile seizures),&#xD;
&#xD;
               -  epilepsy,&#xD;
&#xD;
               -  history of unexplained syncope,&#xD;
&#xD;
               -  recent history of frequent migraine headaches,&#xD;
&#xD;
               -  recent head injury&#xD;
&#xD;
               -  cancer / chemotherapy&#xD;
&#xD;
          -  Subjects with known clotting disorders (self-reported)&#xD;
&#xD;
               -  history of bleeding disorders or personal history of prolonged bleeding from&#xD;
                  injury&#xD;
&#xD;
               -  history of blood clots&#xD;
&#xD;
               -  hemophilia&#xD;
&#xD;
               -  current use of blood thinner: prescription or daily use of aspirin&#xD;
&#xD;
          -  Subjects with severe contact allergies to standard adhesives, latex or other materials&#xD;
             found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or&#xD;
             other medical sensors (self-reported)&#xD;
&#xD;
          -  Subjects with a contact allergy to ultrasound gel.&#xD;
&#xD;
          -  Subjects with prior or known allergies to iodine or lidocaine (or similar&#xD;
             pharmacological agents, e.g. Novocaine)&#xD;
&#xD;
          -  Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test&#xD;
&#xD;
          -  Subject is intoxicated during the time of the visit, or was intoxicated within 24&#xD;
             hours prior to study visit, as reported by the subject, or per study staff judgment.&#xD;
&#xD;
          -  Other known health condition, should be considered upon disclosure in health&#xD;
             assessment form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>At least 30% of the subjects will be female and at least 30% will be male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur Ruiz Cabrera, M.D</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Clinimark Lab</name>
      <address>
        <city>Louisville</city>
        <state>Colorado</state>
        <zip>80027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</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/NCT04456179
org study id: PR2020-363
nct id: NCT04456179
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this study is to evaluate methods to modify blood pressure in humans and
      measure the effectiveness of such methods. A secondary outcome is to evaluate the performance
      of an investigational continuous non-invasive blood pressure (cNIBP) device created by
      Sensifree. The tests will per performed in non-hospitalized subjects under varied controlled
      conditions that include resting blood pressure and non-pharmacologically induced blood
      pressure changes.
On a first visit a screening procedure to verify inclusion / exclusion criteria are met will
      be conducted. On the primary procedure visit, data collection will begin with the subjects
      having the investigational device, ECG sensors, and 1 or more pulse oximetry sensors placed
      on them for data collection and to monitor their safety for the duration of the study. A
      physician will place an arterial line in the radial artery. The Sensifree cNIBP system will
      be calibrated with an oscillometric and/or auscultatory blood pressure cuff measurement taken
      on the arm opposite the arterial line.

      A series of blood pressure changes will be induced, including various combinations of
      methods.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans
time frame: 3-4 hours per subject
description: Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg):
Hand grip
Weight lifting
Leg static effort
measure: Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device
time frame: 3-4 hours per subject
description: Comparison of BP values (Systolic, Diastolic, MAP) that are calculated by the investigational device to the BP values measured by the arterial line during isometric effort comprising a combination of the following isometric efforts on a subject's blood pressure:
Hand grip
Weight lifting
Leg static effort
intervention type: Device
intervention name: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor
description: PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
intervention type: Device
intervention name: Arrow® arterial catheterization kit (Teleflex)
description: Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
criteria: 
gender: All
gender based: Yes
gender description: At least 30% of the subjects will be female and at least 30% will be male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Arthur Ruiz Cabrera, M.D
role: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No