<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/NCT03807830</url>
  </required_header>
  <id_info>
    <org_study_id>18/EE/0304</org_study_id>
    <nct_id>NCT03807830</nct_id>
  </id_info>
  <brief_title>Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery</brief_title>
  <official_title>Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cambridge University Hospitals NHS Foundation Trust</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of&#xD;
      cochlear implants, for patients with Advanced Bionics devices.&#xD;
&#xD;
      The sound recordings created may be useful in aiding the surgeon to better implant the&#xD;
      patient by letting him or her know if they are damaging the ear during implantation in real&#xD;
      time&#xD;
&#xD;
      Patients will be followed up for 1 year post surgery within our trial, and have a further 3&#xD;
      ECochGs performed in the clinic setting, (6 weeks, 6 months, 1 year) through their implants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cochlear implant candidature has changed in the past years. Today many cochlear implant&#xD;
      recipients have some low frequency residual hearing in the ear which is to be implanted. To&#xD;
      help preserve hearing, the electrode array must be inserted extremely carefully. It is&#xD;
      desirable to have real-time feedback relating to progress of the electrode insertion.&#xD;
&#xD;
      One possible tool that might provide this is an electrocochleography (ECochG). A brief&#xD;
      low-frequency acoustic tone at a fixed level is delivered to the external ear canal. This&#xD;
      results in normal movements of the outer and the inner hair cells inside the inner ear. These&#xD;
      movements are known to produce small electrical potentials that have been previously been&#xD;
      sensed by a recording electrode placed on the promontory, or surface of the bone in which the&#xD;
      cochlea is located. Averaging of these recordings in synchrony with the acoustic stimulus&#xD;
      allows the small ECochG signal to be reinforced while any physiological or electrical noise&#xD;
      is averaged out. With ECochG measurements different aspects of the auditory system can be&#xD;
      tested. For the investigators work only the cochlear microphonic, generated by the outer hair&#xD;
      cells will be recorded and analysed.&#xD;
&#xD;
      The Advanced Bionics (AB) implant system is uniquely suited to do such measurements. The aim&#xD;
      of the study is to monitor electrode array insertion during surgery and any residual hearing&#xD;
      function over time in using this tool as a comparison to conventional methods. Subjects will&#xD;
      undergo the study procedure of ECochG measurements, alongside additional standard of care&#xD;
      appointments for the research, pure tone audiometry and impedence measurement. Only a 10&#xD;
      minute ECochG measurement will be the additional research component to the patients clinical&#xD;
      routine as mentioned above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Measure cochlear micro phonic amplitude</measure>
    <time_frame>12 months</time_frame>
    <description>To measure objectively the cochlear micro phonic amplitude either intra or post operatively within initial 12 months of cochlear implant use</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cochlear Implants</condition>
  <condition>Hearing Preservation</condition>
  <arm_group>
    <arm_group_label>One arm feasbility study</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrocochlography</intervention_name>
    <description>Intra-operative ECochG recording via the implant, post operative ECochG measurements. Impedances measured over time.</description>
    <arm_group_label>One arm feasbility study</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between ages of 12 months to 6 years old, and Adults over 18 years old&#xD;
&#xD;
          -  Meets normal candidacy requirements for cochlear implantation&#xD;
&#xD;
          -  Advanced Bionics (AB) implant has been selected for patient at MDT&#xD;
&#xD;
          -  Patient has capacity to consent&#xD;
&#xD;
          -  Patent cochlea as verified by CT or MRI scan&#xD;
&#xD;
          -  No cochlear abnormality that might prevent insertion of the electrode array&#xD;
&#xD;
          -  Measurable residual hearing in the ear to be implanted&#xD;
&#xD;
          -  No additional handicap that would prevent study procedures being followed&#xD;
&#xD;
          -  Agreement to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complex cases where minimal duration of surgery is required. Although ECochG adds less&#xD;
             than 10 minutes to the surgery time.&#xD;
&#xD;
          -  Patients lacking the capacity to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manohar L Bance, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Emmeline Centre for Cochlear Implants</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cambridge University Hospitals NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Sophie Newton</investigator_full_name>
    <investigator_title>Hearing implant nurse. Prof M Bance Chief Investigator.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03807830
org study id: 18/EE/0304
nct id: NCT03807830
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of
      cochlear implants, for patients with Advanced Bionics devices.

      The sound recordings created may be useful in aiding the surgeon to better implant the
      patient by letting him or her know if they are damaging the ear during implantation in real
      time

      Patients will be followed up for 1 year post surgery within our trial, and have a further 3
      ECochGs performed in the clinic setting, (6 weeks, 6 months, 1 year) through their implants.
Cochlear implant candidature has changed in the past years. Today many cochlear implant
      recipients have some low frequency residual hearing in the ear which is to be implanted. To
      help preserve hearing, the electrode array must be inserted extremely carefully. It is
      desirable to have real-time feedback relating to progress of the electrode insertion.

      One possible tool that might provide this is an electrocochleography (ECochG). A brief
      low-frequency acoustic tone at a fixed level is delivered to the external ear canal. This
      results in normal movements of the outer and the inner hair cells inside the inner ear. These
      movements are known to produce small electrical potentials that have been previously been
      sensed by a recording electrode placed on the promontory, or surface of the bone in which the
      cochlea is located. Averaging of these recordings in synchrony with the acoustic stimulus
      allows the small ECochG signal to be reinforced while any physiological or electrical noise
      is averaged out. With ECochG measurements different aspects of the auditory system can be
      tested. For the investigators work only the cochlear microphonic, generated by the outer hair
      cells will be recorded and analysed.

      The Advanced Bionics (AB) implant system is uniquely suited to do such measurements. The aim
      of the study is to monitor electrode array insertion during surgery and any residual hearing
      function over time in using this tool as a comparison to conventional methods. Subjects will
      undergo the study procedure of ECochG measurements, alongside additional standard of care
      appointments for the research, pure tone audiometry and impedence measurement. Only a 10
      minute ECochG measurement will be the additional research component to the patients clinical
      routine as mentioned above.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Measure cochlear micro phonic amplitude
time frame: 12 months
description: To measure objectively the cochlear micro phonic amplitude either intra or post operatively within initial 12 months of cochlear implant use
arm group label: One arm feasbility study
arm group type: Other
intervention type: Procedure
intervention name: Electrocochlography
description: Intra-operative ECochG recording via the implant, post operative ECochG measurements. Impedances measured over time.
arm group label: One arm feasbility study
criteria: 
gender: All
minimum age: 12 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manohar L Bance, MD
role: Principal Investigator
affiliation: The Emmeline Centre for Cochlear Implants
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cambridge University Hospitals NHS Foundation Trust
investigator full name: Sophie Newton
investigator title: Hearing implant nurse. Prof M Bance Chief Investigator.
sharing ipd: Undecided