<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/NCT02968797</url>
  </required_header>
  <id_info>
    <org_study_id>0143-16-MMC</org_study_id>
    <nct_id>NCT02968797</nct_id>
  </id_info>
  <brief_title>Clinical Comparative Study to Validate Performance of SafeSed Prototype Monitoring Endoscopy Under Sedation</brief_title>
  <acronym>SafeSed</acronym>
  <official_title>SafeSed Validation Study, Comparing Performance to Capnography, as a Monitoring Technology of Respiratory Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      SafeSed prototype monitors respiratory parameters by tracking chest movements with optical&#xD;
      and accelerometer markers. The respiratory parameters are compared to respiratory parameters&#xD;
      measured by a spirometer and a capnograph.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients performing endoscopy procedures under sedation at the gastro clinic will be&#xD;
      monitored by SafeSed in addition to being monitored by capnography, used by an anaesthetist.&#xD;
      All patients will be monitored using the same two techniques (SafeSed and Capnography). No&#xD;
      clinical decisions will be made based upon the data generated by the SafeSed system.&#xD;
&#xD;
      The data from all sources will be compared (post factum) to validate SafeSed performance.&#xD;
&#xD;
      The data collected on the SafeSed prototype will not be used for treatment of the patient.&#xD;
&#xD;
      The comparative analysis will be free vto be used by the sponsor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparative data of monitoring respiratory by 2 technologies</measure>
    <time_frame>4 months</time_frame>
    <description>Validation of SafeSed performance by comparing to capnography. The respiratory rate (RR) and end tidal carbon dioxide (ETCO2) levels will be collected into a personal computer, and stored with a continuous time-stamp. RR, tidal volume (TD) and minute ventilatio (MV) calculations using the SafeSed markers chest movements will be stored at the same PC using the same time-stamp. Comparison will show correlation between deterioration events of respiratory parameters. This comparison will be the outcome of off-line analysis.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Apnea</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SafeSed</intervention_name>
    <description>Monitor respiratory parameters</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled to perform endoscopy procedures under sedation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  class 1-3 per American Society Anesthesiologists Physical Status Classification&#xD;
&#xD;
          -  Subject signed Informed Concent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unresolved pulmonary infection requiring active treatment&#xD;
&#xD;
          -  Chronic pulmonary disease&#xD;
&#xD;
          -  Any othe medical condition, that treating physician determines participating in the&#xD;
             study is unadvisable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Fredman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Israel: Clalit Health bServices</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brian Fredman, MD</last_name>
    <phone>052-278-5127</phone>
    <email>fredman.brian@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428331</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian Fredman, MD</last_name>
      <phone>+97297471545</phone>
      <email>Fredman.brian@clalit.org.il</email>
    </contact>
    <contact_backup>
      <last_name>Edna Zohar, MD</last_name>
      <phone>+97297471545</phone>
      <email>Zohar.edna@clalit.org.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 20, 2018</last_update_submitted>
  <last_update_submitted_qc>March 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 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/NCT02968797
org study id: 0143-16-MMC
nct id: NCT02968797
lead sponsor: 
has dmc: No
SafeSed prototype monitors respiratory parameters by tracking chest movements with optical
      and accelerometer markers. The respiratory parameters are compared to respiratory parameters
      measured by a spirometer and a capnograph.
Patients performing endoscopy procedures under sedation at the gastro clinic will be
      monitored by SafeSed in addition to being monitored by capnography, used by an anaesthetist.
      All patients will be monitored using the same two techniques (SafeSed and Capnography). No
      clinical decisions will be made based upon the data generated by the SafeSed system.

      The data from all sources will be compared (post factum) to validate SafeSed performance.

      The data collected on the SafeSed prototype will not be used for treatment of the patient.

      The comparative analysis will be free vto be used by the sponsor.
observational model: Case-Only
time perspective: Retrospective
measure: Comparative data of monitoring respiratory by 2 technologies
time frame: 4 months
description: Validation of SafeSed performance by comparing to capnography. The respiratory rate (RR) and end tidal carbon dioxide (ETCO2) levels will be collected into a personal computer, and stored with a continuous time-stamp. RR, tidal volume (TD) and minute ventilatio (MV) calculations using the SafeSed markers chest movements will be stored at the same PC using the same time-stamp. Comparison will show correlation between deterioration events of respiratory parameters. This comparison will be the outcome of off-line analysis.
intervention type: Device
intervention name: SafeSed
description: Monitor respiratory parameters
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Brian Fredman, MD
role: Principal Investigator
affiliation: Israel: Clalit Health bServices
last name: Brian Fredman, MD
phone: 052-278-5127
email: fredman.brian@clalit.org.il
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
responsible party type: Sponsor
sharing ipd: No