<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/NCT04450290</url>
  </required_header>
  <id_info>
    <org_study_id>MED-EL_CRD_2014_02</org_study_id>
    <nct_id>NCT04450290</nct_id>
  </id_info>
  <brief_title>Dexamethasone-Eluting Cochlear Implant Electrode</brief_title>
  <acronym>CIDEX</acronym>
  <official_title>Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): A First in Human Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MED-EL Elektromedizinische Geräte GesmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MED-EL Elektromedizinische Geräte GesmbH</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>
      A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent&#xD;
      dexamethasone (DEX) into the electrode array. The passive elution of DEX during the&#xD;
      post-implantation period has the purpose of counteracting the increase of the post-operative&#xD;
      impedance induced by the insertion trauma.&#xD;
&#xD;
      The aim of this clinical investigation is to obtain a first experience in use of the&#xD;
      investigational device in the adult clinical population, and to initially assess tools,&#xD;
      techniques and performance outcome measures that may be considered in future clinical studies&#xD;
      of similar devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The principal objective of this study is to exploratively investigate the safety profile of&#xD;
      the device which will be evaluated through the analysis of adverse events during the&#xD;
      follow-up period. For the study to be considered a success, the results of the adverse event&#xD;
      analysis shall never cause an unbalanced risk vs. benefit assessment.&#xD;
&#xD;
      The secondary objectives of this study aim at investigating the usefulness of possible&#xD;
      outcome measures in evaluating the performance of the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">May 5, 2022</completion_date>
  <primary_completion_date type="Actual">May 5, 2022</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>First-in-human, single-arm, exploratory, open-label, prospective, longitudinal, monocentric study</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>10 months</time_frame>
    <description>Safety profile of the device which will be evaluated through the analysis of adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IFT (Impedance Field Telemetry) - impedance</measure>
    <time_frame>10 months</time_frame>
    <description>Impedance Field Telemetry and derived values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrically Evoked Compound Action Potential</measure>
    <time_frame>10 months</time_frame>
    <description>Electrically Evoked Compound Action Potential and derived values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MCL (Maximum Comfortable Loudness)</measure>
    <time_frame>10 months</time_frame>
    <description>Maximum Comfortable Loudness Levels and Thresholds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>THR (Threshold)</measure>
    <time_frame>10 months</time_frame>
    <description>Thresholds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTA (Pure Tone Audiometry) Audiometrical values</measure>
    <time_frame>10 months</time_frame>
    <description>Results from PTA assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hearing Preservation rate</measure>
    <time_frame>10 months</time_frame>
    <description>Rate of Hearing Preservation according to Skarżyński et al.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HSM (Hochmair-Schulz-Moser Sentence) Test</measure>
    <time_frame>10 months</time_frame>
    <description>Speech test in noise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>10 months</time_frame>
    <description>Surgical feedback questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Hearing Loss, Sensorineural</condition>
  <condition>Sensorineural Hearing Loss</condition>
  <arm_group>
    <arm_group_label>single arm - treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be implanted with the investigational device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CIDEXEL implant</intervention_name>
    <description>The newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma.</description>
    <arm_group_label>single arm - treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age of eighteen (18) years at time of enrolment.&#xD;
&#xD;
          -  Severe to profound sensorineural hearing loss on the ipsilateral ear.&#xD;
&#xD;
          -  A functional auditory nerve in the ear to be implanted.&#xD;
&#xD;
          -  Subjects reporting to having used an optimally fit hearing aids for a minimum of three&#xD;
             months before the decision that a cochlear implant (CI) is the preferential option.&#xD;
&#xD;
          -  Cochlea anatomy compatible with the insertion of a +FLEX28 electrode array.&#xD;
&#xD;
          -  Compatibility with a soft surgery approach as per clinical practice at the site.&#xD;
&#xD;
          -  Post-lingual hearing impairment.&#xD;
&#xD;
          -  Subject fulfilling indication criteria for a CI according to the local professional&#xD;
             standards, as reported by the implanting surgeon.&#xD;
&#xD;
          -  General health condition, psychological and emotional condition deemed compatible with&#xD;
             the treatment and tests performed in this study and realistic expectations, as deemed&#xD;
             appropriate by the implanting surgeon.&#xD;
&#xD;
          -  Signed and dated informed consent before the start of any study-specific procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of compliance with any inclusion criterion.&#xD;
&#xD;
          -  Previously having received a cochlear implant on the ear chosen for placing the IMD&#xD;
             (Investigational Medical Device).&#xD;
&#xD;
          -  Evidence of ossification or any other cochlear anomaly that might prevent complete&#xD;
             insertion of the electrode array or might cause increased risk of infection (e.g.&#xD;
             dysplastic cochlea), as confirmed by medical examination and/or as per CT/MRT&#xD;
             (Computed Tomography/Magnetic Resonance Tomography).&#xD;
&#xD;
          -  Evidence of anatomic abnormalities that would prevent appropriate placement of the&#xD;
             stimulator housing in the bone of the skull.&#xD;
&#xD;
          -  Evidence of otosclerosis.&#xD;
&#xD;
          -  Known allergic reaction or intolerance to the materials used in the implant (including&#xD;
             medical grade silicone, platinum, iridium, parylene c, dexamethasone).&#xD;
&#xD;
          -  Known absence of cochlear development or if the cause of deafness is non-functionality&#xD;
             of the auditory nerve and/or the upper auditory pathway.&#xD;
&#xD;
          -  Evidence of active external or middle ear infection or history of recurrent middle ear&#xD;
             infection in the ear to be implanted.&#xD;
&#xD;
          -  Evidence of perforated tympanic membrane in the ear to be implanted.&#xD;
&#xD;
          -  Patient reporting immunosuppressive therapy or corticosteroids therapy in the 4 weeks&#xD;
             before enrolment.&#xD;
&#xD;
          -  Evidence of concomitant use of medicinal substances that, in the opinion of the&#xD;
             investigator, could alter the therapeutic efficacy of dexamethasone.&#xD;
&#xD;
          -  Unwillingness or inability of the candidate to comply with all investigational&#xD;
             requirements.&#xD;
&#xD;
          -  Evidence of medical contraindications to surgery of the middle and inner ear and&#xD;
             anaesthesia.&#xD;
&#xD;
          -  Additional disabilities that would prevent or restrict participation in the&#xD;
             audiological and medical evaluations required of the clinical investigation.&#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>Thomas Lenarz, Prof. Prof. h. c. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MHH - Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</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>
    <mesh_term>Deafness</mesh_term>
    <mesh_term>Hearing Loss, Sensorineural</mesh_term>
  </condition_browse>
  <!-- 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/NCT04450290
org study id: MED-EL_CRD_2014_02
nct id: NCT04450290
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent
      dexamethasone (DEX) into the electrode array. The passive elution of DEX during the
      post-implantation period has the purpose of counteracting the increase of the post-operative
      impedance induced by the insertion trauma.

      The aim of this clinical investigation is to obtain a first experience in use of the
      investigational device in the adult clinical population, and to initially assess tools,
      techniques and performance outcome measures that may be considered in future clinical studies
      of similar devices.
The principal objective of this study is to exploratively investigate the safety profile of
      the device which will be evaluated through the analysis of adverse events during the
      follow-up period. For the study to be considered a success, the results of the adverse event
      analysis shall never cause an unbalanced risk vs. benefit assessment.

      The secondary objectives of this study aim at investigating the usefulness of possible
      outcome measures in evaluating the performance of the device.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: First-in-human, single-arm, exploratory, open-label, prospective, longitudinal, monocentric study
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Adverse Events
time frame: 10 months
description: Safety profile of the device which will be evaluated through the analysis of adverse events
measure: IFT (Impedance Field Telemetry) - impedance
time frame: 10 months
description: Impedance Field Telemetry and derived values
measure: Electrically Evoked Compound Action Potential
time frame: 10 months
description: Electrically Evoked Compound Action Potential and derived values
measure: MCL (Maximum Comfortable Loudness)
time frame: 10 months
description: Maximum Comfortable Loudness Levels and Thresholds
measure: THR (Threshold)
time frame: 10 months
description: Thresholds
measure: PTA (Pure Tone Audiometry) Audiometrical values
time frame: 10 months
description: Results from PTA assessment
measure: Hearing Preservation rate
time frame: 10 months
description: Rate of Hearing Preservation according to Skarżyński et al.
measure: HSM (Hochmair-Schulz-Moser Sentence) Test
time frame: 10 months
description: Speech test in noise
measure: Questionnaire
time frame: 10 months
description: Surgical feedback questionnaire
arm group label: single arm - treatment
arm group type: Experimental
description: All subjects will be implanted with the investigational device.
intervention type: Device
intervention name: CIDEXEL implant
description: The newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma.
arm group label: single arm - treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Lenarz, Prof. Prof. h. c. Dr. med.
role: Principal Investigator
affiliation: Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
mesh term: Hearing Loss, Sensorineural