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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02905305




Registration number
NCT02905305
Ethics application status
Date submitted
14/09/2016
Date registered
19/09/2016
Date last updated
19/09/2016

Titles & IDs
Public title
Cochlear Implant With Anti-Inflammatory Agent
Scientific title
Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone
Secondary ID [1] 0 0
CLTD 5495
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Contour Advance electrode with controlled dose of dexamethasone base
Treatment: Devices - Contour Advance electrode

Experimental: CA with dexamethasone base - Contour Advance electrode with controlled dose of dexamethasone base

Active Comparator: Contour Advance - Standard Contour Advance electrode array


Treatment: Devices: Contour Advance electrode with controlled dose of dexamethasone base
The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.

Treatment: Devices: Contour Advance electrode
Standard Contour Advance electrode

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Surgical feedback - Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode
Timepoint [1] 0 0
During surgery
Primary outcome [2] 0 0
Safety of Combined Device - Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device
Timepoint [2] 0 0
Monitoring over 24 months
Secondary outcome [1] 0 0
Electrode impedance
Timepoint [1] 0 0
Testing over 24 months
Secondary outcome [2] 0 0
Electrically evoked compound action potential (ECAP)
Timepoint [2] 0 0
Testing over 24 months

Eligibility
Key inclusion criteria
1. Duration severe to profound hearing impairment in implanted ear of less than or equal
to 30 years

2. Post-lingual hearing impairment defined as onset of hearing loss at greater than two
years of age

3. Evidence of Pneumovax vaccination within three years of implantation date (for
subjects to be implanted with the investigational device)
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ossification or any other cochlear anomaly that might prevent complete insertion of
the electrode array or increased risk of infection (i.e. dysplastic cochlea), as
confirmed by medical examination and imaging including MRI

2. Current use of grommets or evidence of tympanic membrane perforation

3. Known allergic reaction to dexamethasone or similar medicine

4. Diagnosis of Auditory Neuropathy

5. Active middle ear infection or history of middle ear infection within past two years

6. Unrealistic expectations on the part of the subject regarding the possible benefits,
risks, and limitations that are inherent to the surgical procedure and use of the
prosthetic device

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

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The HEARing CRC - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Hearing Cooperative Research Centre
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Cochlear
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Victoria Eye and Ear Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
St Vincent's Hospital Melbourne
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Westmead Hospital, New South Wales
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In an effort to further preserve residual acoustic hearing after cochlear implantation, it
may be beneficial to incorporate anti-inflammatory agents into the electrode array for
passive elution over a time course after implantation. This study aims to assess the ease and
effectiveness of such an electrode design, and to assess the preliminary safety of use of
such a device in the post-operative period. This study is a first-time-in-human study of the
investigational device.

In the first instance, the aim of the current investigation is to obtain first experience in
use of a Combined Device in the adult clinical population, and to assess tools and techniques
that may be considered in future clinical studies of similar devices.
Trial website
https://clinicaltrials.gov/show/NCT02905305
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Robert Cowan, PhD, MBA
Address 0 0
Country 0 0
Phone 0 0
+613 9035 5346
Fax 0 0
Email 0 0
rcowan@hearingcrc.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02905305