<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/NCT02190877</url>
  </required_header>
  <id_info>
    <org_study_id>Perm-IRB-001</org_study_id>
    <nct_id>NCT02190877</nct_id>
  </id_info>
  <brief_title>Monitoring Subjects With Fluid-Management Issues In the Home Environment</brief_title>
  <official_title>A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baxter Healthcare Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to validate ease-of-use for the CoVa Monitoring System, along with&#xD;
      simple statistical parameters such as reproducibility and inter-subject agreement between&#xD;
      test and reference devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study has the following objectives:&#xD;
&#xD;
      Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if&#xD;
      subjects could use the test device on a daily basis, and if the components of this system&#xD;
      (Sensor, Gateway, Web-based System) were indeed operational&#xD;
&#xD;
      Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in&#xD;
      any skin irritation&#xD;
&#xD;
      Objective 3: determine that the long-term reproducibility of measurements made by the test&#xD;
      device is as good or better than the long-term reproducibility of the reference device&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ease of Use</measure>
    <time_frame>Each subject will be measured once per weekday over a 6 week period</time_frame>
    <description>Investigate ease of use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SKin irritation and reproducibility</measure>
    <time_frame>Each subject will be measured once per weekday over a 6 week period</time_frame>
    <description>Determine if subjects had skin irritation from daily use for 30 days. Determine the long-term reproducibility of the measurements from the test device versus the reference device</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>Heart Failure</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Subjects taking diuretic medication</arm_group_label>
    <description>All subjects will be in the same group, Cohort 1</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be volunteers from Riverside Meadows Estates. Subjects will be taking one or&#xD;
        more diuretic medication(s) prescribed by a physician&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.&#xD;
&#xD;
          -  Subject will have a current prescription for a diuretic medication.&#xD;
&#xD;
          -  Subject and/or legally authorized person/representative is willing to undergo the&#xD;
             Informed Consent process prior to enrollment in the study.&#xD;
&#xD;
          -  Subject is a candidate for this study based on the PI's opinion and knowledge of the&#xD;
             subject's condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is participating in another clinical study that may affect the results of&#xD;
             either study.&#xD;
&#xD;
          -  Subject is unable or not willing to wear electrode patches as required.&#xD;
&#xD;
          -  Subject has skin sensitivity to adhesive or hydrogel materials used in electrode&#xD;
             patches.&#xD;
&#xD;
          -  Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist&#xD;
             device.&#xD;
&#xD;
          -  Subject is considered by the PI to be medically unsuitable for study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Banet, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baxter Healthcare Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Riverside Meadows</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Impedance</keyword>
  <keyword>Fluids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT02190877
org study id: Perm-IRB-001
nct id: NCT02190877
lead sponsor: 
has dmc: No
This study is designed to validate ease-of-use for the CoVa Monitoring System, along with
      simple statistical parameters such as reproducibility and inter-subject agreement between
      test and reference devices.
The study has the following objectives:

      Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if
      subjects could use the test device on a daily basis, and if the components of this system
      (Sensor, Gateway, Web-based System) were indeed operational

      Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in
      any skin irritation

      Objective 3: determine that the long-term reproducibility of measurements made by the test
      device is as good or better than the long-term reproducibility of the reference device
observational model: Cohort
time perspective: Retrospective
measure: Ease of Use
time frame: Each subject will be measured once per weekday over a 6 week period
description: Investigate ease of use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational
measure: SKin irritation and reproducibility
time frame: Each subject will be measured once per weekday over a 6 week period
description: Determine if subjects had skin irritation from daily use for 30 days. Determine the long-term reproducibility of the measurements from the test device versus the reference device
arm group label: Cohort 1: Subjects taking diuretic medication
description: All subjects will be in the same group, Cohort 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
last name: Matthew Banet, PhD
role: Principal Investigator
affiliation: Baxter Healthcare Corporation
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure