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
October 4, 2021
Completion Date
July 2024
Primary Completion Date
July 2023
Eligibility Criteria
Inclusion Criteria:
- Post-lingual, bilateral, moderate (≥ 40 dB HL) to profound sensorineural hearing loss
at 250, 500and 1000 Hz and profound high-frequency hearing loss, defined by a
pure-tone average (PTA) threshold, 2000 through 8000 Hz, ≥ 90 dB HL.
- 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
Aaron Parkinson, +61459377289, [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
Aaron Parkinson, Study Director, Cochlear
Verification Date
October 2022