<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/NCT04472208</url>
  </required_header>
  <id_info>
    <org_study_id>123.04-2017-GES-0005</org_study_id>
    <nct_id>NCT04472208</nct_id>
  </id_info>
  <brief_title>AMS Evaluation Study</brief_title>
  <official_title>Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GE Healthcare</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to evaluate the operational and functional features of the Ambulatory Monitor&#xD;
      Solution (AMS) as well as the ease of use of the system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is going to be conducted to collect feedback from the users about operation of AMS&#xD;
      collect parameter raw data from patients in hospital ward setting using the investigational&#xD;
      system for use in current and future AMS engineering and regulatory purposes as deemed&#xD;
      appropriate by the Sponsor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2021</start_date>
  <completion_date type="Actual">October 14, 2021</completion_date>
  <primary_completion_date type="Actual">October 14, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>User feedback survey about the use of the Ambulatory Monitoring Solution</measure>
    <time_frame>5 days</time_frame>
    <description>The feedback from the clinical users about operational features, alarms, user experience and ease of use of Ambulatory Monitoring Solution will be collected.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues</measure>
    <time_frame>1 year</time_frame>
    <description>The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues. The descriptive statistical methods will be used to analyze AE and SAE data.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Patient Monitoring</condition>
  <arm_group>
    <arm_group_label>Ambulatory Monitoring Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ambulatory monitoring solution</intervention_name>
    <description>Subjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor.</description>
    <arm_group_label>Ambulatory Monitoring Solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female aged 18 years or older (≥18 years);&#xD;
&#xD;
          2. Able and willing to provide written informed consent independently.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have previously participated in this study (no subject may participate more than&#xD;
             once);&#xD;
&#xD;
          2. Have an implantable pacemaker;&#xD;
&#xD;
          3. Diagnosed with infection requiring isolation; OR&#xD;
&#xD;
          4. Known to be pregnant and/or breast feeding;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meera Joshi, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Marys Hospital, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>November 2, 2021</last_update_submitted>
  <last_update_submitted_qc>November 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04472208
org study id: 123.04-2017-GES-0005
nct id: NCT04472208
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A study to evaluate the operational and functional features of the Ambulatory Monitor
      Solution (AMS) as well as the ease of use of the system.
The study is going to be conducted to collect feedback from the users about operation of AMS
      collect parameter raw data from patients in hospital ward setting using the investigational
      system for use in current and future AMS engineering and regulatory purposes as deemed
      appropriate by the Sponsor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: User feedback survey about the use of the Ambulatory Monitoring Solution
time frame: 5 days
description: The feedback from the clinical users about operational features, alarms, user experience and ease of use of Ambulatory Monitoring Solution will be collected.
measure: Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues
time frame: 1 year
description: The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues. The descriptive statistical methods will be used to analyze AE and SAE data.
arm group label: Ambulatory Monitoring Solution
arm group type: Experimental
description: The evaluable device is a secondary monitoring device and no decisions/diagnosis will be made from these devices.
intervention type: Device
intervention name: Ambulatory monitoring solution
description: Subjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor.
arm group label: Ambulatory Monitoring Solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Meera Joshi, MBBS
role: Principal Investigator
affiliation: St. Marys Hospital, London
facility: 
country: United Kingdom
responsible party type: Sponsor