Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001593224
Ethics application status
Approved
Date submitted
20/09/2018
Date registered
25/09/2018
Date last updated
12/07/2023
Date data sharing statement initially provided
4/02/2020
Date results information initially provided
16/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility of the Cochlear™ Nucleus® Cochlear Implant in a Newly Implanted Adult Population
Scientific title
Feasibility of the Cochlear™ Nucleus® Cochlear Implant in a Newly Implanted Adult Population.
Secondary ID [1] 296140 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hearing loss
309727 0
Condition category
Condition code
Ear 308536 308536 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cochlear Prosthesis Implantation.
All participants will receive the same treatment- implantation of the totally implantable cochlear implant TI1012 (surgery) and over night stay in hospital.
ENT surgeon will administer the intervention and will be follow up up by Audiologists in Cochlear clinic
There will be a 2 week gap from implantation (surgery) to activation at the clinic
Intervention code [1] 312469 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307511 0
1. Mean speech perception performance for an open-set CNC monosyllabic word recognition measure with the external Sound Processor (EH mode) in the unilateral listening condition at six months post-activation
Timepoint [1] 307511 0
6 months post activation
Primary outcome [2] 307512 0
2. Mean speech perception performance for AuSTIN sentence in noise recognition measure with the external Sound Processor (EH mode) in the unilateral listening condition at six months post-activation
Timepoint [2] 307512 0
six months post-activation
Primary outcome [3] 307513 0
3. Mean speech perception performance for an open-set CNC monosyllabic word recognition measure without the external Sound Processor (IH mode) in the unilateral listening condition at six months post-activation
Timepoint [3] 307513 0
six months post-activation
Secondary outcome [1] 352119 0
1. Patient Satisfaction Survey (PSS) at six months post-activation
Timepoint [1] 352119 0
6 months post activation
Secondary outcome [2] 352249 0
2. Tinnitus Handicap Inventory (THI) score at six months post activation
Timepoint [2] 352249 0
6 months post activation
Secondary outcome [3] 352250 0
3. Mean global Health Utility Index mark 3 (HUI3) score at six months post-activation
Timepoint [3] 352250 0
6 months post activation

Eligibility
Key inclusion criteria
1. A bilateral or unilateral moderately severe to profound postlinguistic sensorineural hearing loss and who have compromised functional hearing with hearing aids or receive no benefit with hearing aids.
2. Fluent speaker in the local language used to assess clinical performance as judged by the investigator.
3. Eighteen years of age or older at the time of enrolment with no upper age limit.
4. A 30 day trial and/or experience with appropriately fit hearing aids.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Deafness due to lesions of the acoustic nerve or central auditory pathway.
2. Active middle-ear infections.
3. Tympanic membrane perforation.
4. Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
5. Evidence of severe-to-profound hearing loss prior to 5 years of age.
6. Pre-existing cochlear or bone conduction implant.
7. Medical or psychological conditions that contraindicate general anaesthesia or surgery.
8. Additional disabilities that may affect the subject’s participation or safety during the clinical investigation.
9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator.
10. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.
11. Existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leaks
12. Recurrent episodes of bacterial meningitis.
13. Pre-existing skin condition that could jeopardize wound healing as judged by the investigator e.g. psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.
14. Pre-existing medical condition that requires serial MRI and CT.
15. Pre-existing medical condition of peripheral neuropathy.

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/09/2018
Date of last participant enrolment
Anticipated
1/06/2020
Actual
28/02/2020
Date of last data collection
Anticipated
31/03/2022
Actual
20/04/2022
Sample size
Target
11
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11954 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 24100 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 300725 0
Commercial sector/Industry
Name [1] 300725 0
Cochlear Ltd
Country [1] 300725 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Ltd
Address
1 University Ave
Macquarie University, NSW, 2109
Country
Australia
Secondary sponsor category [1] 300266 0
None
Name [1] 300266 0
N/A
Address [1] 300266 0
N/A
Country [1] 300266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301507 0
Royal Victorian Eye and Ear Hospital Human Research & Ethics Committee [EC00244]
Ethics committee address [1] 301507 0
32 Gisborne Street
East Melbourne, VIC, 3002
Ethics committee country [1] 301507 0
Australia
Date submitted for ethics approval [1] 301507 0
06/06/2018
Approval date [1] 301507 0
31/08/2018
Ethics approval number [1] 301507 0
16/1304H

Summary
Brief summary
The purpose of the feasibility study is to examine speech perception outcomes (quiet and noise) and safety (adverse events and adverse device effects) with the cochlear implant in eleven newly implanted adults who meet the eligibility criteria for the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87234 0
A/Prof Robert Briggs
Address 87234 0
Melbourne Ear Specialists
Suite 222, Level 2, 100 Victoria Parade,
East Melbourne Vic 3002 Australia
Country 87234 0
Australia
Phone 87234 0
+61 3 9650 0522
Fax 87234 0
Email 87234 0
[email protected]
Contact person for public queries
Name 87235 0
A/Prof Robert Briggs
Address 87235 0
Prof Robert Briggs
Suite 222, Level 2, 100 Victoria Parade,
East Melbourne Vic 3002 Australia
Country 87235 0
Australia
Phone 87235 0
+61 3 9650 0522
Fax 87235 0
Email 87235 0
[email protected]
Contact person for scientific queries
Name 87236 0
A/Prof Robert Briggs
Address 87236 0
Prof Robert Briggs
Suite 222, Level 2, 100 Victoria Parade,
East Melbourne Vic 3002 Australia
Country 87236 0
Australia
Phone 87236 0
+61 3 9650 0522
Fax 87236 0
Email 87236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Cochlear do not have an approved platform for public sharing of IPD collected in this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19687Study protocol    376044-(Uploaded-30-06-2023-06-15-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 376044-(Uploaded-30-06-2023-06-12-40)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.