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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/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/ct2/show/NCT04750642