<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/NCT02199457</url>
  </required_header>
  <id_info>
    <org_study_id>LMD_CT_001</org_study_id>
    <nct_id>NCT02199457</nct_id>
  </id_info>
  <brief_title>A Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)</brief_title>
  <official_title>An Open Label, Clinical Performance Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Léman Micro Devices SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Léman Micro Devices SA</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>
      A medical device study to assess the clinical accuracy and equivalence to reference devices&#xD;
      of the SVSS to satisfy the requirements of the recognised applicable international standards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen&#xD;
      saturation (Sp02), blood pressure, body temperature and respiration rate. These results will&#xD;
      be compared for accuracy with the results obtained using standard vital sign measurement&#xD;
      equipment on the same subject.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Device development not completed&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards.</measure>
    <time_frame>DAY 1</time_frame>
    <description>Accuracy of investigational device compared to the reference devices.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>SVSS and reference devices</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Vital signs will be measured on the same subject with the reference devices and with the SVSS. The subject will have blood pressure, pulse, blood oxygen, body temperature and respiration rate measured using standard equipment. The same subject will then use the investigational device which measures all vital signs at the same time, by placing the index finger on a sensor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SVSS and reference devices</intervention_name>
    <description>Blood pressure will be measured with standard mercury manometer</description>
    <arm_group_label>SVSS and reference devices</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SVSS and reference devices</intervention_name>
    <description>Body temperature taken with infrared thermometer</description>
    <arm_group_label>SVSS and reference devices</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SVSS and reference devices</intervention_name>
    <description>Pulse rate and Sp02 measured with a reference pulse oximter. The pulse oximeter is just clipped to the end of the finger.</description>
    <arm_group_label>SVSS and reference devices</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SVSS and reference devices</intervention_name>
    <description>Measurement of respiration rate</description>
    <arm_group_label>SVSS and reference devices</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers, male or female, 18 yrs or older, willing and able to participate&#xD;
             and sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Elliott</last_name>
    <role>Study Director</role>
    <affiliation>Sponsor GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>EPFL</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</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/NCT02199457
org study id: LMD_CT_001
nct id: NCT02199457
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A medical device study to assess the clinical accuracy and equivalence to reference devices
      of the SVSS to satisfy the requirements of the recognised applicable international standards.
The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen
      saturation (Sp02), blood pressure, body temperature and respiration rate. These results will
      be compared for accuracy with the results obtained using standard vital sign measurement
      equipment on the same subject.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Primary outcome is satisfactory evidence of substantial equivalence of each of the five vital signs with the reference devices within the ranges specified by the standards.
time frame: DAY 1
description: Accuracy of investigational device compared to the reference devices.
arm group label: SVSS and reference devices
arm group type: Other
description: Vital signs will be measured on the same subject with the reference devices and with the SVSS. The subject will have blood pressure, pulse, blood oxygen, body temperature and respiration rate measured using standard equipment. The same subject will then use the investigational device which measures all vital signs at the same time, by placing the index finger on a sensor.
intervention type: Device
intervention name: SVSS and reference devices
description: Blood pressure will be measured with standard mercury manometer
arm group label: SVSS and reference devices
intervention type: Device
intervention name: SVSS and reference devices
description: Body temperature taken with infrared thermometer
arm group label: SVSS and reference devices
intervention type: Device
intervention name: SVSS and reference devices
description: Pulse rate and Sp02 measured with a reference pulse oximter. The pulse oximeter is just clipped to the end of the finger.
arm group label: SVSS and reference devices
intervention type: Device
intervention name: SVSS and reference devices
description: Measurement of respiration rate
arm group label: SVSS and reference devices
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chris Elliott
role: Study Director
affiliation: Sponsor GmbH
facility: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No