xml: <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/NCT06027749</url>
    </required_header>
    <id_info>
      <org_study_id>REMI-23-01</org_study_id>
      <nct_id>NCT06027749</nct_id>
    </id_info>
    <brief_title>Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System.</brief_title>
    <acronym>REMI</acronym>
    <official_title>Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With REMI.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Epitel, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Epitel, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™)&#xD;
        ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for&#xD;
        extended periods (14 - 28 days) in patients presenting with questionable seizure&#xD;
        characterization. The main questions it aims to answer are: • Can more seizure events be&#xD;
        recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating&#xD;
        clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG?&#xD;
        Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28)&#xD;
        days in their home/community setting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective study to quantify Epitel's™ Remote EEG Monitoring System's (REMI™)&#xD;
        ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for&#xD;
        extended periods (14 - 28 days). Patients presenting with questionable seizure&#xD;
        characterization that are scheduling a conventional at home ambulatory EEG (Amb EEG) and who&#xD;
        meet the study inclusion and exclusion criteria will be prescribed a REMI system.&#xD;
  &#xD;
        The purpose of this study is to demonstrate that the REMI system is able to record EEG data&#xD;
        that clinicians can use to identify ictal events over extended periods, and that extended&#xD;
        clinical EEG data is valuable in the diagnosis and treatment of seizure related symptoms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</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>
      <intervention_model_description>Prospective Cohort</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Ictal Events Identified in fourteen (14) days.</measure>
      <time_frame>Fourteen (14) days</time_frame>
      <description>Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first three days will be compared to the number of seizures identified during days one (1) to fourteen (14).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Extended Use</measure>
      <time_frame>Twenty-eight (28) days</time_frame>
      <description>Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first fourteen (14) days will be compared to the number of seizures identified during all twenty-eight (28) days.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">65</enrollment>
    <condition>Epilepsy</condition>
    <condition>Seizures</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Epitel's™ Remote EEG Monitoring System's (REMI™)</intervention_name>
      <description>Ambulatory electroencephalography (EEG) monitoring</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients have a reported history of seizures (epileptic, non-epileptic, or unknown),&#xD;
  &#xD;
            -  Have a minimum reported seizure rate of one every two weeks,&#xD;
  &#xD;
            -  Are prescribed an ambulatory EEG study as part of routine care,&#xD;
  &#xD;
            -  Is Male or Female between the ages of 18 and 70,&#xD;
  &#xD;
            -  Can understand and sign written informed consent, or have a legal guardian provide&#xD;
               consent,&#xD;
  &#xD;
            -  The Patient (or Primary Caregiver) must be competent to follow all study procedures,&#xD;
  &#xD;
            -  The Patient must be willing to use the System for a prolonged period (up to 30 days),&#xD;
               for a minimum of 20 hours/day.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Is sensitive or allergic to medical acrylics, silicones, or hydrogels,&#xD;
  &#xD;
            -  Is enrolled in another investigational drug or device trial,&#xD;
  &#xD;
            -  Is homeless or in a home without a power supply, or&#xD;
  &#xD;
            -  Cannot read, speak, or understand English (and does not have a translator).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Medical University of South Carolina</name>
        <address>
          <city>Charleston</city>
          <state>South Carolina</state>
          <zip>29407</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jonathan Halford</last_name>
        <phone>843-607-8319</phone>
        <email>halfordj@musc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Robin Bulgarino</last_name>
        <phone>843-792-1115</phone>
        <email>bulgarino@musc.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Jonathan Halford, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>EEG Monitoring</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Seizures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No IPD will be shared with other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027749
  org study id: REMI-23-01
  nct id: NCT06027749
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™)
        ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for
        extended periods (14 - 28 days) in patients presenting with questionable seizure
        characterization. The main questions it aims to answer are: • Can more seizure events be
        recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating
        clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG?
        Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28)
        days in their home/community setting.
  This is a prospective study to quantify Epitel's™ Remote EEG Monitoring System's (REMI™)
        ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for
        extended periods (14 - 28 days). Patients presenting with questionable seizure
        characterization that are scheduling a conventional at home ambulatory EEG (Amb EEG) and who
        meet the study inclusion and exclusion criteria will be prescribed a REMI system.
  
        The purpose of this study is to demonstrate that the REMI system is able to record EEG data
        that clinicians can use to identify ictal events over extended periods, and that extended
        clinical EEG data is valuable in the diagnosis and treatment of seizure related symptoms.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective Cohort
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Ictal Events Identified in fourteen (14) days.
  time frame: Fourteen (14) days
  description: Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first three days will be compared to the number of seizures identified during days one (1) to fourteen (14).
  measure: Extended Use
  time frame: Twenty-eight (28) days
  description: Epileptiform seizure activity as identified by three independent board-certified epileptologists assessing data collected by REMI. The number of seizures identified in the first fourteen (14) days will be compared to the number of seizures identified during all twenty-eight (28) days.
  intervention type: Device
  intervention name: Epitel's™ Remote EEG Monitoring System's (REMI™)
  description: Ambulatory electroencephalography (EEG) monitoring
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Seizures
  sharing ipd: No
  ipd description: No IPD will be shared with other researchers.