Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04750642




Registration number
NCT04750642
Ethics application status
Date submitted
31/01/2021
Date registered
11/02/2021
Date last updated
11/09/2023

Titles & IDs
Public title
Cochlear Implant With Dexamethasone Eluting Electrode Array
Scientific title
Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study
Secondary ID [1] 0 0
CLTD5759
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sensorineural Hearing Loss 0 0
Bilateral Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CI632D
Treatment: Devices - CI632

Experimental: CI632D Investigational Medical Device (IMD) -

Placebo comparator: CI632 Comparator Device -


Treatment: Devices: CI632D
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)

Treatment: Devices: CI632
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of Monopolar (MP1+2) impedance measurement (kOhms) between randomisation groups measured through Custom Sound software during clinical visits.
Timepoint [1] 0 0
Six months
Primary outcome [2] 0 0
Change in speech perception performance (pre-recorded CNC words in quiet in sound booth testing) compared to pre-operative baseline measured during clinical visits.
Timepoint [2] 0 0
Six months
Secondary outcome [1] 0 0
Comparison of rate and type of device related adverse events between randomisation groups.
Timepoint [1] 0 0
Six months and twelve months
Secondary outcome [2] 0 0
Comparison of speech perception performance (pre-recorded CNC words in quiet and AzBio sentences in quiet in sound booth testing) between randomisation groups measured during clinical visit.
Timepoint [2] 0 0
Six months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2024
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 0 0
Westmead Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
6150 - Murdoch
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
6150 - Sydney
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland
Country [14] 0 0
New Zealand
State/province [14] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NAMSA
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Avania
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Vanderbilt University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04750642
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aaron Parkinson
Address 0 0
Cochlear
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04750642