Cochlear Implant With Dexamethasone Eluting Electrode Array

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Sensorineural hearing loss
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Brief Title

Cochlear Implant With Dexamethasone Eluting Electrode Array

Official Title

Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study

Brief Summary

      An evaluation of Cochlear's cochlear implant electrode array which passively elutes
      dexamethasone for a defined period of time to help reduce inflammatory responses.

Detailed Description

      The primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone
      eluting electrode through reduction in electrode impedances as compared to a standard
      electrode and the improvement of speech recognition from preoperative baseline. The secondary
      objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as
      similar to a standard electrode by comparison of adverse events and speech outcomes.

Study Type

Interventional

Primary Outcome

Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits.

Secondary Outcome

 Comparison of rate and type of device related adverse events between randomisation groups.

Condition

Sensorineural Hearing Loss

Intervention

CI632D

Study Arms / Comparison Groups

 CI632D Investigational Medical Device (IMD)
Description:

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

120

Start Date

July 2021

Completion Date

December 2023

Primary Completion Date

June 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Moderate to profound post-lingual, bilateral, moderate to profound sensorineural
             hearing loss.

          -  18 years or older at time of consent

        Exclusion Criteria:

          -  Abnormal cochlear and middle ear anatomy

          -  History with cochlear implant surgery

          -  Allergy to dexamethasone

          -  Women who are pregnant or plan to become pregnant

          -  Unable/unwilling to comply to study requirements

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +61296116898, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT04750642

Organization ID

CLTD5759

Responsible Party

Sponsor

Study Sponsor

Cochlear

Collaborators

 NAMSA

Study Sponsor

, ,

Verification Date

June 2021