<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/NCT03294681</url>
  </required_header>
  <id_info>
    <org_study_id>CLTD5676</org_study_id>
    <nct_id>NCT03294681</nct_id>
  </id_info>
  <brief_title>Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms</brief_title>
  <official_title>Trans-impedance Matrix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cochlear</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cochlear</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this descriptive study is to collect and describe the characteristics of objective&#xD;
      measures to explore the specificity of algorithms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">May 29, 2019</completion_date>
  <primary_completion_date type="Actual">May 29, 2019</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>Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over</measure>
    <time_frame>at surgery, within one minute</time_frame>
    <description>Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery.&#xD;
Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">153</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Cochlear Implant Recipients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Objective measures with CSEP</intervention_name>
    <description>Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients</description>
    <arm_group_label>Cochlear Implant Recipients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Routine patients undergoing a standard cochlear implantation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidate for cochlear implantation with the CI532 or CI512 devices&#xD;
&#xD;
          -  18 years of age or older at the time of enrolment&#xD;
&#xD;
          -  Normal cochlea anatomy, established via pre-operative Computer Tomography&#xD;
&#xD;
          -  Willingness to participate in and to comply with all requirements of the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior cochlear implantation in the ear to be implanted&#xD;
&#xD;
          -  Ossification or any other cochlear anomaly that might prevent complete insertion of&#xD;
             the electrode array&#xD;
&#xD;
          -  Abnormal cochlear anatomy on pre-operative Computer Tomography or Magnetic Resonance&#xD;
             Imaging&#xD;
&#xD;
          -  Additional handicaps that would prevent participation in evaluations&#xD;
&#xD;
          -  Pregnant and breast feeding women, prisoners, or anyone in custody&#xD;
&#xD;
          -  Unrealistic expectations on the part of the subject, regarding the possible benefits,&#xD;
             risks and limitations that are inherent to the procedure&#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>Bart Volckaerts, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cochlear</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HEARing CRC</name>
      <address>
        <city>Carlton</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hals-Nasen-Ohren-Klinik Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Hals-, Nasen-, Ohrenheilkunde Universitätsklinikum Frankfurt Goethe-Universität</name>
      <address>
        <city>Frankfurt am Main</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig- Holstein - Campus Kiel Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario Insular Materno Infantil</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Germany</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>May 20, 2020</results_first_submitted>
  <results_first_submitted_qc>June 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2020</results_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03294681/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03294681/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>153 participants were recruited in six centres from 03 October 2017 to 29 May 2019.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cochlear Implant Recipients</title>
          <description>CI532 and CI512 cochlear implant recipients</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="153"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>153 participants were recruited and one patient withdrew consent. The data of this participant were not analyzed.</population>
      <group_list>
        <group group_id="B1">
          <title>Cochlear Implant Recipients</title>
          <description>CI532 and CI512 cochlear implant recipients</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="152"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" lower_limit="19" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</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_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over</title>
        <description>Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery.&#xD;
Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.</description>
        <time_frame>at surgery, within one minute</time_frame>
        <population>148 ears were analyzed from 145 participants (with three bilateral participants providing 148 ears). From the 152 baseline participants, seven were excluded from the analysis: for three participants, no transimpedance data were obtained intra-operatively and for four participants the transimpedance data showed measurement abnormalities.</population>
        <group_list>
          <group group_id="O1">
            <title>Cochlear Implant Recipients</title>
            <description>CI532 and CI512 cochlear implant recipients</description>
          </group>
        </group_list>
        <measure>
          <title>Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over</title>
          <description>Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery.&#xD;
Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.</description>
          <population>148 ears were analyzed from 145 participants (with three bilateral participants providing 148 ears). From the 152 baseline participants, seven were excluded from the analysis: for three participants, no transimpedance data were obtained intra-operatively and for four participants the transimpedance data showed measurement abnormalities.</population>
          <units>Percentage of ears</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <units_analyzed>ears</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>ears</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" lower_limit="95.8" upper_limit="99.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cochlear Implant Recipients</title>
          <description>CI532 and CI512 cochlear implant recipients</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="153"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pass out related to heat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="153"/>
              </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="153"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Investigators can publish and/or present their own data and process their data with their own algorithms. At study end 2 joint publications by the clinical investigators/sponsor are planned with the Coordinating Investigator writing the publication. All abstract/publication must be reviewed by the sponsor at least 30 days in advance. If a publication contains information that the sponsor finds worth protecting the sponsor has the right to delay the publication/presentation for 90 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nicole Neben</name_or_title>
      <organization>Cochlear</organization>
      <phone>+4951154277220</phone>
      <email>nneben@cochlear.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/NCT03294681
org study id: CLTD5676
nct id: NCT03294681
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this descriptive study is to collect and describe the characteristics of objective
      measures to explore the specificity of algorithms.
observational model: Cohort
time perspective: Prospective
measure: Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over
time frame: at surgery, within one minute
description: Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery.
Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.
arm group label: Cochlear Implant Recipients
intervention type: Device
intervention name: Objective measures with CSEP
description: Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients
arm group label: Cochlear Implant Recipients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bart Volckaerts, PhD
role: Study Director
affiliation: Cochlear
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Germany
country: Spain
responsible party type: Sponsor
mesh term: Hearing Loss
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 