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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05619575




Registration number
NCT05619575
Ethics application status
Date submitted
9/11/2022
Date registered
17/11/2022

Titles & IDs
Public title
Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR)
Scientific title
A Pre-market, Open-label, Within Subject Study, of Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients Compared With the CP1150 Sound Processor and Their Current Sound Processor.
Secondary ID [1] 0 0
CLTD5836
Universal Trial Number (UTN)
Trial acronym
POLAR
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CP1170 sound processor
Treatment: Devices - CP1150 Sound processor

Experimental: CP1170 sound processor - Take home use of CP1170 Sound processor for 2 weeks followed by in booth testing of the investigational device.

Active comparator: CP1150 sound processor - In booth testing of CP1150 sound processor.


Treatment: Devices: CP1170 sound processor
The CP 1170 sound processor will be used to determine the hearing performance with the new implementation of ForwardFocus in SCAN 2 (SCAN 2 FF), as assessed by speech perception in noise.

Treatment: Devices: CP1150 Sound processor
Active comparator off the ear sound processor.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus)
Timepoint [1] 0 0
One day (in booth testing)
Secondary outcome [1] 0 0
Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus)
Timepoint [1] 0 0
One day (in booth testing)
Secondary outcome [2] 0 0
Speech perception in quiet with CP1170 and CP1150 Sound Processors
Timepoint [2] 0 0
One day (in booth testing)
Secondary outcome [3] 0 0
Subjective acceptance and satisfaction between the CP1170 sound processor and the subject's own processor.
Timepoint [3] 0 0
2 weeks
Secondary outcome [4] 0 0
Subjective hearing performance between the CP1170 sound processor and the subject's own processor
Timepoint [4] 0 0
One day

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Post lingually deafened
3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3).
4. At least 6 months experience with a cochlear hearing implant
5. At least 3 months experience with any Nucleus sound processor and SCAN program
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
7. Willingness to participate in and to comply with all requirements of the protocol
8. Fluent speaker in English as determined by the investigator
9. 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. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures
3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation, as determined by the Investigator.
6. 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
Other
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
Other
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2024
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Sydne
Recruitment hospital [1] 0 0
Cochlear Macquarie - Macquarie
Recruitment postcode(s) [1] 0 0
2109 - Macquarie

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05619575