<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/NCT04485741</url>
  </required_header>
  <id_info>
    <org_study_id>SL-RS-AEMC01</org_study_id>
    <nct_id>NCT04485741</nct_id>
  </id_info>
  <brief_title>Strados System at Center of Excellence</brief_title>
  <official_title>Clinical Utility of Strados System in Periodically Recording Auscultation to Provide Replay Capability and Telemedicine Monitoring of Inpatients After Initial Clinical Assessment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Strados Labs, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Strados Labs, Inc.</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>
      Listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians&#xD;
      in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic&#xD;
      testing to admit, follow and discharge patients from hospital. Of these, only auscultation&#xD;
      routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown&#xD;
      that for more than a decade, readmission after discharge for an exacerbation of COPD or&#xD;
      severe asthma (or chronic heart failure) remains a major problem. The Strados System has been&#xD;
      designed to extend the range of lung sound recording both geographically and temporally to&#xD;
      improve the standard of care when access to continuous monitoring has been replaced by&#xD;
      periodic or no monitoring. The primary purpose of this study is to assess the clinical&#xD;
      utility of the Strados System in enabling periodic recording and reviewing of breath sounds&#xD;
      in patients with chronic respiratory diseases, either in the ICU, or in less continuously&#xD;
      monitored settings, including after inpatient discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 28, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical utility as assessed by the PI</measure>
    <time_frame>Periodic recording over 12 to 24 hours</time_frame>
    <description>To assess the clinical utility of Strados Systems in enabling periodic recording and reviewing of lung breath sounds of inpatients with chronic respiratory diseases in ICU , and less continuously monitored settings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical utility as assessed by other clinicians</measure>
    <time_frame>Periodic recording over 12 to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of RESP data with other measures of patient status.</measure>
    <time_frame>Periodic recording over 12 to 24 hours</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Copd</condition>
  <condition>Asthma</condition>
  <condition>Covid19</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RESP</intervention_name>
    <description>The RESP device will be placed on the patient for periodic recording of auscultory sound.</description>
    <other_name>Strados System</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who are admitted for exacerbation of chronic airway disease (COPD or severe&#xD;
        asthma) or for respiratory distress symptoms associated with SARS-COV-2 infection for 1 to&#xD;
        3 weeks to ICU or specialty floor with access to telemedicine monitoring&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Potential study participants will be recruited from within the Einstein Center of&#xD;
        Excellence. Individuals who meet all of the following criteria are eligible for enrollment&#xD;
        as study participants:&#xD;
&#xD;
          1. Males and females between the ages of 18-80:&#xD;
&#xD;
             With documented physician-diagnosed COPD (chronic bronchitis dominant) or severe&#xD;
             asthma, as defined either by the American Thoracic Society or the World Health&#xD;
             Organization who are admitted for exacerbation, including those with active or&#xD;
             suspected SARS-COV-2 infection&#xD;
&#xD;
             OR&#xD;
&#xD;
             Who are admitted with respiratory distress symptoms associated with SARS-COV-2&#xD;
             infection&#xD;
&#xD;
          2. Able to provide informed consent&#xD;
&#xD;
          3. Able to follow study procedures&#xD;
&#xD;
          4. Clinician assessment of the patient's current SARS-COV-2 status: negative or unlikely&#xD;
             to be infected, RTPCR positive, or untested by clinically suspected&#xD;
&#xD;
          5. Accessible by telephone upon discharge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects who meet ANY of the following criteria are not eligible for enrollment:&#xD;
&#xD;
          1. Inability or unwillingness of the participant to give written informed consent&#xD;
&#xD;
          2. History of adverse reaction or allergy to Tegaderm&#xD;
&#xD;
          3. Unwillingness or inability to comply with study procedures&#xD;
&#xD;
          4. Scheduled for thoracic procedure&#xD;
&#xD;
          5. Inaccessible by telephone post-discharge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Albert Einstein Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04485741
org study id: SL-RS-AEMC01
nct id: NCT04485741
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Listening to breath sounds with the stethoscope/auscultation is used by pulmonary physicians
      in conjunction with pulmonary function, signs and symptoms, oxygen saturation and diagnostic
      testing to admit, follow and discharge patients from hospital. Of these, only auscultation
      routinely ceases upon discharge from Hospital. Healthcare utilization statistics have shown
      that for more than a decade, readmission after discharge for an exacerbation of COPD or
      severe asthma (or chronic heart failure) remains a major problem. The Strados System has been
      designed to extend the range of lung sound recording both geographically and temporally to
      improve the standard of care when access to continuous monitoring has been replaced by
      periodic or no monitoring. The primary purpose of this study is to assess the clinical
      utility of the Strados System in enabling periodic recording and reviewing of breath sounds
      in patients with chronic respiratory diseases, either in the ICU, or in less continuously
      monitored settings, including after inpatient discharge.
observational model: Cohort
time perspective: Prospective
measure: Clinical utility as assessed by the PI
time frame: Periodic recording over 12 to 24 hours
description: To assess the clinical utility of Strados Systems in enabling periodic recording and reviewing of lung breath sounds of inpatients with chronic respiratory diseases in ICU , and less continuously monitored settings.
measure: Clinical utility as assessed by other clinicians
time frame: Periodic recording over 12 to 24 hours
measure: Correlation of RESP data with other measures of patient status.
time frame: Periodic recording over 12 to 24 hours
intervention type: Device
intervention name: RESP
description: The RESP device will be placed on the patient for periodic recording of auscultory sound.
other name: Strados System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided