Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000090516
Ethics application status
Approved
Date submitted
5/12/2023
Date registered
1/02/2024
Date last updated
3/06/2024
Date data sharing statement initially provided
1/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Actual-use of CP1110 Sound Processor, CP1175 Sound Processor and associated system components in experienced adult CI1000 Series cochlear implant recipients.
Scientific title
A pre-market, open-label, within-subject, interventional study examining acceptability in actual-use scenarios of CP1110 Sound Processor, CP1175 Sound Processor and associated system components in experienced adult CI1000 Series cochlear implant recipients.
Secondary ID [1] 310642 0
CLTD5847
Universal Trial Number (UTN)
Trial acronym
LUMINA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjects with at least one CI1000 series cochlear implant. 331525 0
Condition category
Condition code
Ear 328263 328263 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational medical devices include the CP1175 sound processor and the CP1110 sound processor used in conjunction with an investigational version of Custom Sound Pro fitting software, the Nucleus Smart App and a software measuring postoperative implant function.

At study visits, subjects will participate in procedures which closely follow routine audiological care and management. During 2 planned visits, and up to 6 additional ad hoc visits, experienced audiologists will program each of the investigational sound processors for subjects to trial in the clinic, including engaging in live conversations with investigator(s). Additionally, there will be a minimum of 2 take-home periods requiring subjects to use the off-the-ear (CP1175) and the behind-the-ear sound processors (CP1110) during their preferred waking hours and provide their subjective feedback on sound quality, comfort and ease of use. Visits are anticipated to be up to 2 hours in duration. Visits 1 and 2 will be a minimum of 2 weeks apart, and subsequent ad hoc visits are likely to occur monthly within the 12-month study duration.
Intervention code [1] 327044 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336124 0
The acceptability of the CP1110 Sound Processor with CP1110 Slimline Coil (CI1000) in actual-use scenarios.
Timepoint [1] 336124 0
During scheduled visits, ad-hoc visits and take-home periods whilst the subject is using the CP1110 sound processor over the course of their enrolment.
Primary outcome [2] 336638 0
The acceptability of the CP1175 Sound Processor in actual-use scenarios
Timepoint [2] 336638 0
During scheduled visits, ad-hoc visits and take-home periods whilst the subject is using the CP1175 sound processor over the course of their enrolment.
Secondary outcome [1] 426921 0
The acceptability of clinical workflows required to fit the sound processors under investigation, as assessed by the investigator(s).
Timepoint [1] 426921 0
During scheduled visits and ad-hoc visits whilst the investigator is performing procedures which closely follow routine audiological care and management.

Eligibility
Key inclusion criteria
1. Aged 18 years or older.
2. Post lingually deafened.
3. Implanted with at least one CI1032.
4. At least 2 months experience with a cochlear hearing implant.
5. Willingness to participate in and to comply with all requirements of the protocol.
6. Fluent speaker in English as determined by the investigator.
7. Willing and able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Additional disabilities that would prevent participation in evaluations.
2. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
3. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
4. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation, as determined by the Investigator.
5. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2024
Actual
8/04/2024
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314858 0
Commercial sector/Industry
Name [1] 314858 0
Cochlear Ltd
Country [1] 314858 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Ltd
Address
1 University Avenue, Macquarie University, NSW, 2109
Country
Australia
Secondary sponsor category [1] 316852 0
None
Name [1] 316852 0
Address [1] 316852 0
Country [1] 316852 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313857 0
Royal Victorian Eye and Ear Hospital HREC (RVEEH)
Ethics committee address [1] 313857 0
32 Gisbourne Street, East Melbourne, VIC, 3002
Ethics committee country [1] 313857 0
Australia
Date submitted for ethics approval [1] 313857 0
20/11/2023
Approval date [1] 313857 0
01/03/2024
Ethics approval number [1] 313857 0
23/1591H

Summary
Brief summary
This is a pre-market, prospective, single-site, open-label, within-subject, non-randomised interventional study of acceptance of the CP1175 and CP1110 Sound Processors through use with adult cochlear implant recipients in real world scenarios. The investigational medical devices include an off-the-ear sound processor, a behind-the-ear sound processor, used in conjunction with investigational versions of fitting software, the Nucleus Smart App and a software measuring postoperative implant function. The objectives of the investigation are to collect device and procedure-related deficiencies to optimise clinical care for recipients of the investigational CI1000 Series cochlear implants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129578 0
A/Prof Karyn Galvin
Address 129578 0
HEARnet Ltd. 550 Swanston Street Carlton, VIC. 3053
Country 129578 0
Australia
Phone 129578 0
+61 0407052505
Fax 129578 0
Email 129578 0
kgalvin@unimelb.edu.au
Contact person for public queries
Name 129579 0
Ms Kylie McClelland
Address 129579 0
Cochlear CTLD - 1 University Avenue, Macquarie University, NSW, 2109.
Country 129579 0
Australia
Phone 129579 0
+61 409359535
Fax 129579 0
Email 129579 0
kmcclelland@cochlear.com
Contact person for scientific queries
Name 129580 0
Ms Emjay Mashal
Address 129580 0
Cochlear CTLD - 1 University Avenue, Macquarie University, NSW, 2109.
Country 129580 0
Australia
Phone 129580 0
+61 409359535
Fax 129580 0
Email 129580 0
emashal@cochlear.com

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. Data will not be shared for this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.