<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/NCT02200523</url>
  </required_header>
  <id_info>
    <org_study_id>ns053116_SARA_electrode</org_study_id>
    <secondary_id>R44NS053116</secondary_id>
    <nct_id>NCT02200523</nct_id>
  </id_info>
  <brief_title>Self Abrading Rapidly Applied Electrode Validation</brief_title>
  <acronym>SARA</acronym>
  <official_title>Self Abrading Rapidly Applied (SARA) Electrode Phase II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cleveland Medical Devices Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Cleveland Medical Devices Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining&#xD;
      multiple steps that burden conventional EEG procedures into one. The investigators believe&#xD;
      that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20&#xD;
      minutes) with additional time savings on cleanup. Reducing the hookup time required for the&#xD;
      EEG recording will make EEG more feasible in time critical situations and will improve&#xD;
      patient care and service. The clinical testing in Phase II will investigate patient&#xD;
      acceptance, clinician acceptance, time savings, and signal quality for 3 different&#xD;
      environments: the large hospital institution, a small rural hospital setting and in an&#xD;
      emergency department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining&#xD;
      multiple steps that burden conventional EEG procedures into one. This proposed single-use&#xD;
      electrode will consist of a Snap Top, Ag/AgCl Snap Conductor, Conductive Adhesive, and&#xD;
      Abrader Tines in a custom molded housing and packed on a backing sheet. After removing the&#xD;
      backing, the technician simply parts the hair with one hand and with the other hand rubs the&#xD;
      electrode back and forth and then presses the electrode into position on the scalp. The&#xD;
      proposed system combines the cumbersome and time-consuming skin preparation, electrode&#xD;
      preparation and electrode fixation into one easy step. The investigators believe that the&#xD;
      proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with&#xD;
      additional time savings on cleanup. Reducing the hookup time required for the EEG recording&#xD;
      will make EEG more feasible in time critical situations and will improve patient care and&#xD;
      service.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode</measure>
    <time_frame>up to 1 hour</time_frame>
    <description>The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)</condition>
  <arm_group>
    <arm_group_label>SARA electrode</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>new electrode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gold cup</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>gold standard</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SARA electrode</intervention_name>
    <arm_group_label>SARA electrode</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gold cup</intervention_name>
    <arm_group_label>Gold cup</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult and teenage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  young children&#xD;
&#xD;
          -  damaged scalp skin&#xD;
&#xD;
          -  sensitive or allergic to electrode paste&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Weimer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Great Lakes NeuroTechnologies Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MetroHealth Research Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>February 5, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>July 22, 2019</results_first_submitted>
  <results_first_submitted_qc>August 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 13, 2020</results_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EEG</keyword>
  <keyword>electrode</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SARA Electrode</title>
          <description>new electrode&#xD;
SARA electrode</description>
        </group>
        <group group_id="P2">
          <title>Gold Cup</title>
          <description>gold standard&#xD;
Gold cup</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SARA Electrode</title>
          <description>new electrode&#xD;
SARA electrode</description>
        </group>
        <group group_id="B2">
          <title>Gold Cup</title>
          <description>gold standard&#xD;
Gold cup</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <population>anonymous data did not include specific age information</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>anonymous data did not include gender information</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode</title>
        <description>The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.</description>
        <time_frame>up to 1 hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SARA Electrode</title>
            <description>new electrode&#xD;
SARA electrode</description>
          </group>
          <group group_id="O2">
            <title>Gold Cup</title>
            <description>gold standard&#xD;
Gold cup</description>
          </group>
        </group_list>
        <measure>
          <title>Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode</title>
          <description>The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" spread="10"/>
                    <measurement group_id="O2" value="45" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>duration of the testing (&lt;1 hour)</time_frame>
      <desc>ALL Adverse Events were monitored during the test by the clinician. Due to low risk of the procedure no subject was considered to be at risk for Mortality nor Serious Adverse Events but if one should occur during the test the clinician would observe and report.</desc>
      <group_list>
        <group group_id="E1">
          <title>SARA Electrode</title>
          <description>new electrode&#xD;
SARA electrode</description>
        </group>
        <group group_id="E2">
          <title>Gold Cup</title>
          <description>gold standard&#xD;
Gold cup</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sarah Weimer</name_or_title>
      <organization>Cleveland Medical Devices</organization>
      <phone>216-791-6720</phone>
      <email>sweimer@clevemed.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02200523
org study id: ns053116_SARA_electrode
secondary id: R44NS053116
nct id: NCT02200523
lead sponsor: 
collaborator: 
has dmc: No
The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining
      multiple steps that burden conventional EEG procedures into one. The investigators believe
      that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20
      minutes) with additional time savings on cleanup. Reducing the hookup time required for the
      EEG recording will make EEG more feasible in time critical situations and will improve
      patient care and service. The clinical testing in Phase II will investigate patient
      acceptance, clinician acceptance, time savings, and signal quality for 3 different
      environments: the large hospital institution, a small rural hospital setting and in an
      emergency department.
The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining
      multiple steps that burden conventional EEG procedures into one. This proposed single-use
      electrode will consist of a Snap Top, Ag/AgCl Snap Conductor, Conductive Adhesive, and
      Abrader Tines in a custom molded housing and packed on a backing sheet. After removing the
      backing, the technician simply parts the hair with one hand and with the other hand rubs the
      electrode back and forth and then presses the electrode into position on the scalp. The
      proposed system combines the cumbersome and time-consuming skin preparation, electrode
      preparation and electrode fixation into one easy step. The investigators believe that the
      proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with
      additional time savings on cleanup. Reducing the hookup time required for the EEG recording
      will make EEG more feasible in time critical situations and will improve patient care and
      service.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode
time frame: up to 1 hour
description: The time it takes in seconds to properly place the SARA electrodes and standard gold cup electrodes will be recorded and compared.
arm group label: SARA electrode
arm group type: Experimental
description: new electrode
arm group label: Gold cup
arm group type: Active Comparator
description: gold standard
intervention type: Device
intervention name: SARA electrode
arm group label: SARA electrode
intervention type: Device
intervention name: Gold cup
arm group label: Gold cup
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Weimer
role: Principal Investigator
affiliation: Great Lakes NeuroTechnologies Inc.
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 