<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/NCT03042949</url>
  </required_header>
  <id_info>
    <org_study_id>0265-16-MMC</org_study_id>
    <nct_id>NCT03042949</nct_id>
  </id_info>
  <brief_title>An Optical System for Measuring Blood Pressure</brief_title>
  <official_title>Correlation of Blood Pressure Measurements Using an Optical System for Measuring Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</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>
      An assesment of an optical system that measures blood pressure on the finger -Elfor 1 device.&#xD;
      The system is based on a small optical sensor that emits coherent light into the skin and&#xD;
      collects the reflected light from the red blood cells in the blood vessels in the skin under&#xD;
      the sensor. The sensor is able to detect the pulse wave and blood pressure can be measured.&#xD;
&#xD;
      The investigators plan to measure blood pressure with the new sensor in patients who are&#xD;
      attending the Hypertension Clinic at Meir Hospital or are undergoing hemodialysis to validate&#xD;
      the sensor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If the blood flow is temporarily interrupted by inflating a small pneumatic cuff at the root&#xD;
      of the finger, blood flow is occluded and the pulse wave disappears. As the pressure in the&#xD;
      cuff is released, blood flow returns, the pulse wave is again detected and blood pressure can&#xD;
      be measured. This apparatus is easy to use and will allow simplified monitoring of blood&#xD;
      pressure contains the laser source and optical sensors that measure the reflected light.&#xD;
&#xD;
      The investigators proposed to validate the sensor by measuring the blood pressure in patients&#xD;
      with this optical sensor and also by standard plethysmography. The investigators plan to&#xD;
      measure participants with low, normal and high blood pressure in order to assess the accuracy&#xD;
      and reliability of the new device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 15, 2018</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>
    <intervention_model_description>Subjects will have their blood pressure measured by standard plethysmography and with a new optical device</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure reading</measure>
    <time_frame>three hours</time_frame>
    <description>Measurements will be performed with a standard plethysmograph and with a new sensor</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Blood Pressure Disorders</condition>
  <arm_group>
    <arm_group_label>Blood pressure measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients requiring blood pressure measurement will have their blood pressure measured in the standard manner by plethysmography, and then with the Elfor -1 device , the new optical sensor, in order to determine the performance of the new sensor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood pressure measurement</intervention_name>
    <description>Blood pressure measurement with a standard plethysmograph</description>
    <arm_group_label>Blood pressure measurement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood pressure measurement with the new device</intervention_name>
    <description>Blood pressure measurement with the optical sensor, Elfor -1 device.</description>
    <arm_group_label>Blood pressure measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients on hemodialysis or visiting the hypertension outpatient clinic at Meir&#xD;
             Medical Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 8, 2017</last_update_submitted>
  <last_update_submitted_qc>February 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>Naomi Nacasch</investigator_full_name>
    <investigator_title>Principle Invastigator</investigator_title>
  </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/NCT03042949
org study id: 0265-16-MMC
nct id: NCT03042949
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An assesment of an optical system that measures blood pressure on the finger -Elfor 1 device.
      The system is based on a small optical sensor that emits coherent light into the skin and
      collects the reflected light from the red blood cells in the blood vessels in the skin under
      the sensor. The sensor is able to detect the pulse wave and blood pressure can be measured.

      The investigators plan to measure blood pressure with the new sensor in patients who are
      attending the Hypertension Clinic at Meir Hospital or are undergoing hemodialysis to validate
      the sensor.
If the blood flow is temporarily interrupted by inflating a small pneumatic cuff at the root
      of the finger, blood flow is occluded and the pulse wave disappears. As the pressure in the
      cuff is released, blood flow returns, the pulse wave is again detected and blood pressure can
      be measured. This apparatus is easy to use and will allow simplified monitoring of blood
      pressure contains the laser source and optical sensors that measure the reflected light.

      The investigators proposed to validate the sensor by measuring the blood pressure in patients
      with this optical sensor and also by standard plethysmography. The investigators plan to
      measure participants with low, normal and high blood pressure in order to assess the accuracy
      and reliability of the new device.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects will have their blood pressure measured by standard plethysmography and with a new optical device
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Blood pressure reading
time frame: three hours
description: Measurements will be performed with a standard plethysmograph and with a new sensor
arm group label: Blood pressure measurement
arm group type: Experimental
description: Patients requiring blood pressure measurement will have their blood pressure measured in the standard manner by plethysmography, and then with the Elfor -1 device , the new optical sensor, in order to determine the performance of the new sensor.
intervention type: Device
intervention name: Blood pressure measurement
description: Blood pressure measurement with a standard plethysmograph
arm group label: Blood pressure measurement
intervention type: Device
intervention name: Blood pressure measurement with the new device
description: Blood pressure measurement with the optical sensor, Elfor -1 device.
arm group label: Blood pressure measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: Naomi Nacasch
investigator title: Principle Invastigator
sharing ipd: No