Dexamethasone-Eluting Cochlear Implant Electrode

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Brief Title

Dexamethasone-Eluting Cochlear Implant Electrode

Official Title

Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): A First in Human Study

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Adverse Events

Secondary Outcome

 IFT (Impedance Field Telemetry) - impedance

Condition

Hearing Loss, Sensorineural

Intervention

CIDEXEL implant

Study Arms / Comparison Groups

 single arm - treatment
Description:  All subjects will be implanted with the investigational device.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

June 30, 2020

Completion Date

July 1, 2021

Primary Completion Date

July 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Minimum age of eighteen (18) years at time of enrolment.

          -  Severe to profound sensorineural hearing loss on the ipsilateral ear.

          -  A functional auditory nerve in the ear to be implanted.

          -  Subjects reporting to having used an optimally fit hearing aids for a minimum of three
             months before the decision that a cochlear implant (CI) is the preferential option.

          -  Cochlea anatomy compatible with the insertion of a +FLEX28 electrode array.

          -  Compatibility with a soft surgery approach as per clinical practice at the site.

          -  Post-lingual hearing impairment.

          -  Subject fulfilling indication criteria for a CI according to the local professional
             standards, as reported by the implanting surgeon.

          -  General health condition, psychological and emotional condition deemed compatible with
             the treatment and tests performed in this study and realistic expectations, as deemed
             appropriate by the implanting surgeon.

          -  Signed and dated informed consent before the start of any study-specific procedure.

        Exclusion Criteria:

          -  Lack of compliance with any inclusion criterion.

          -  Previously having received a cochlear implant on the ear chosen for placing the IMD
             (Investigational Medical Device).

          -  Evidence of ossification or any other cochlear anomaly that might prevent complete
             insertion of the electrode array or might cause increased risk of infection (e.g.
             dysplastic cochlea), as confirmed by medical examination and/or as per CT/MRT
             (Computed Tomography/Magnetic Resonance Tomography).

          -  Evidence of anatomic abnormalities that would prevent appropriate placement of the
             stimulator housing in the bone of the skull.

          -  Evidence of otosclerosis.

          -  Known allergic reaction or intolerance to the materials used in the implant (including
             medical grade silicone, platinum, iridium, parylene c, dexamethasone).

          -  Known absence of cochlear development or if the cause of deafness is non-functionality
             of the auditory nerve and/or the upper auditory pathway.

          -  Evidence of active external or middle ear infection or history of recurrent middle ear
             infection in the ear to be implanted.

          -  Evidence of perforated tympanic membrane in the ear to be implanted.

          -  Patient reporting immunosuppressive therapy or corticosteroids therapy in the 4 weeks
             before enrolment.

          -  Evidence of concomitant use of medicinal substances that, in the opinion of the
             investigator, could alter the therapeutic efficacy of dexamethasone.

          -  Unwillingness or inability of the candidate to comply with all investigational
             requirements.

          -  Evidence of medical contraindications to surgery of the middle and inner ear and
             anaesthesia.

          -  Additional disabilities that would prevent or restrict participation in the
             audiological and medical evaluations required of the clinical investigation.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas Lenarz, Prof. Prof. h. c. Dr. med., 0043577885591, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT04450290

Organization ID

MED-EL_CRD_2014_02


Responsible Party

Sponsor

Study Sponsor

MED-EL Elektromedizinische Geräte GesmbH


Study Sponsor

Thomas Lenarz, Prof. Prof. h. c. Dr. med., Principal Investigator, Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover


Verification Date

July 2020