<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/NCT02200601</url>
  </required_header>
  <id_info>
    <org_study_id>SEIPHER_CLIN_002</org_study_id>
    <nct_id>NCT02200601</nct_id>
  </id_info>
  <brief_title>Pre-Market Algorithm Validation Study</brief_title>
  <official_title>Pre-Market Algorithm Validation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heart Force Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heart Force Medical Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study sponsor has developed a patented medical device called Seipher Wellness. This is a&#xD;
      non-invasive medical device that assesses heart health based on established cardiac&#xD;
      parameters; timing events of the cardiac cycle. These are specific parameters captured and&#xD;
      analyzed by the device. A ratio of two specific timing parameters provides an assessment of&#xD;
      the subject's overall heart health. The aim of this study is to validate the device algorithm&#xD;
      across a range of subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic Time Intervals (STI) value</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Seipher Wellness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Seipher Wellness</intervention_name>
    <arm_group_label>Seipher Wellness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  able to understand the informed consent document&#xD;
&#xD;
          -  willing to participate&#xD;
&#xD;
          -  ambulatory volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals with visible scar(s) or deformity in the test area of the chest&#xD;
&#xD;
          -  non-ambulatory subjects&#xD;
&#xD;
          -  enrolled in another concurrent study or trial&#xD;
&#xD;
          -  exercised excessively within the last 4 hours&#xD;
&#xD;
          -  unwilling to sign informed consent&#xD;
&#xD;
          -  female subjects who are pregnant, suspected or planning to become pregnant or&#xD;
             breast-feeding&#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>Geoff Houlton, MB ChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart Force Medical</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Integrative Naturopathic Medical Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>February 11, 2015</last_update_submitted>
  <last_update_submitted_qc>February 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Seipher Wellness</keyword>
  <keyword>algorithm</keyword>
  <keyword>secure samples of SGC waveform</keyword>
  <keyword>volunteers</keyword>
  <keyword>validation</keyword>
  <keyword>heart health algorithm</keyword>
  <!-- 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/NCT02200601
org study id: SEIPHER_CLIN_002
nct id: NCT02200601
lead sponsor: 
has dmc: No
The study sponsor has developed a patented medical device called Seipher Wellness. This is a
      non-invasive medical device that assesses heart health based on established cardiac
      parameters; timing events of the cardiac cycle. These are specific parameters captured and
      analyzed by the device. A ratio of two specific timing parameters provides an assessment of
      the subject's overall heart health. The aim of this study is to validate the device algorithm
      across a range of subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Systolic Time Intervals (STI) value
time frame: Day 1
arm group label: Seipher Wellness
arm group type: Experimental
intervention type: Device
intervention name: Seipher Wellness
arm group label: Seipher Wellness
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Geoff Houlton, MB ChB
role: Principal Investigator
affiliation: Heart Force Medical
facility: 
country: Canada
responsible party type: Sponsor