<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/NCT03237923</url>
  </required_header>
  <id_info>
    <org_study_id>2016H0069</org_study_id>
    <nct_id>NCT03237923</nct_id>
  </id_info>
  <brief_title>Evaluation of the EasySense System in Congestive Heart Failure</brief_title>
  <official_title>Evaluation of the EasySense System in Congestive Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Memphis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</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>
      The EasySense device is a non-invasive device designed to measure lung fluid in patients with&#xD;
      Congestive Heart Failure (CHF). This study seeks to evaluate the efficacy of the EasySense&#xD;
      system in measuring lung fluid volume.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Across the globe, Congestive Heart Failure (CHF) continues to be the leading cause of&#xD;
      mortality and hospitalizations in the 21st century. Despite advancements, prognosis often&#xD;
      remains poor and mortality high. Congestive Heart Failure diagnoses are often characterized&#xD;
      by frequent hospitalizations and re-admissions, and early detection of pulmonary edema, a&#xD;
      chief characteristic of worsening heart failure, may have positive implications in patients'&#xD;
      quality of life and frequency of hospitalizations. The EasySense device is a non-invasive&#xD;
      device designed to measure lung fluid in patients with CHF. Similar to ultrasound technology,&#xD;
      the device uses radiofrequency waves to assess fluid status. The device is placed on the bare&#xD;
      skin of the chest and held in place for approximately 60 seconds to obtain a reading.&#xD;
&#xD;
      This study seeks to evaluate the efficacy of the EasySense system in measuring lung fluid&#xD;
      volume. Seventy-five patients are sought for enrollment. Patients will be enrolled during&#xD;
      their hospital stay, and will be asked to maintain daily EasySense measurements, in addition&#xD;
      to other measurements, for thirty days post-discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of volume status to EasySense measurements</measure>
    <time_frame>30 days</time_frame>
    <description>Patient volume status extracted from medical records will be compared to what the EasySense device measures.</description>
  </primary_outcome>
  <enrollment type="Actual">47</enrollment>
  <condition>Congestive Heart Failure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EasySense device</intervention_name>
    <description>Implementation of EasySense device during hospitalization and daily post-discharge for thirty days.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study seeks to enroll patients over the age of 21, diagnosed with congestive heart&#xD;
        failure, who are admitted to the hospital for acute decompensated heart failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current hospitalization for acute decompensated heart failure requiring IV diuretics&#xD;
             or vasoactive drugs&#xD;
&#xD;
          -  NYHA class II-IV&#xD;
&#xD;
          -  Willing and able to participate in index and follow-up measurements&#xD;
&#xD;
          -  Able to speak, read, and write in English&#xD;
&#xD;
          -  Knows how to use a smartphone&#xD;
&#xD;
          -  Preference for patients who undergo a right heart catheterization or continuous&#xD;
             pulmonary artery monitoring upon admission or during hospitalization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or planned treatments with any inotropic agents or mechanical support (LVAD,&#xD;
             intra-aortic balloon pump, invasive mechanically assisted ventilation) at time of&#xD;
             enrollment&#xD;
&#xD;
          -  Requiring demand pacing&#xD;
&#xD;
          -  Prior heart transplant&#xD;
&#xD;
          -  End-stage renal disease on hemodialysis&#xD;
&#xD;
          -  Physical deformities in the thorax area that may prevent proper application of&#xD;
             EasySense device, as assessed by investigator&#xD;
&#xD;
          -  Sign of local rib cage or thoracic lesion or any illness which may be aggravated or&#xD;
             cause significant discomfort from application of EasySense device, as assessed by&#xD;
             investigator&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Sitaramesh Emani</investigator_full_name>
    <investigator_title>Dr. Sitaramesh Emani, MD</investigator_title>
  </responsible_party>
  <keyword>fluid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <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/NCT03237923
org study id: 2016H0069
nct id: NCT03237923
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The EasySense device is a non-invasive device designed to measure lung fluid in patients with
      Congestive Heart Failure (CHF). This study seeks to evaluate the efficacy of the EasySense
      system in measuring lung fluid volume.
Across the globe, Congestive Heart Failure (CHF) continues to be the leading cause of
      mortality and hospitalizations in the 21st century. Despite advancements, prognosis often
      remains poor and mortality high. Congestive Heart Failure diagnoses are often characterized
      by frequent hospitalizations and re-admissions, and early detection of pulmonary edema, a
      chief characteristic of worsening heart failure, may have positive implications in patients'
      quality of life and frequency of hospitalizations. The EasySense device is a non-invasive
      device designed to measure lung fluid in patients with CHF. Similar to ultrasound technology,
      the device uses radiofrequency waves to assess fluid status. The device is placed on the bare
      skin of the chest and held in place for approximately 60 seconds to obtain a reading.

      This study seeks to evaluate the efficacy of the EasySense system in measuring lung fluid
      volume. Seventy-five patients are sought for enrollment. Patients will be enrolled during
      their hospital stay, and will be asked to maintain daily EasySense measurements, in addition
      to other measurements, for thirty days post-discharge.
observational model: Other
time perspective: Prospective
measure: Comparison of volume status to EasySense measurements
time frame: 30 days
description: Patient volume status extracted from medical records will be compared to what the EasySense device measures.
intervention type: Device
intervention name: EasySense device
description: Implementation of EasySense device during hospitalization and daily post-discharge for thirty days.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Sitaramesh Emani
investigator title: Dr. Sitaramesh Emani, MD
mesh term: Heart Failure
sharing ipd: No