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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02852330




Registration number
NCT02852330
Ethics application status
Date submitted
3/06/2016
Date registered
2/08/2016
Date last updated
12/11/2019

Titles & IDs
Public title
Intracochlear Potentials: Volta Study
Scientific title
Intracochlear Potentials: Intraoperative and Post-operative Measurement Clinical Investigation
Secondary ID [1] 0 0
CLTD5663
Secondary ID [2] 0 0
CLTD5663
Universal Trial Number (UTN)
Trial acronym
CLTD5663
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 - SA16 research software
Treatment: Devices - CS19 (1.6.2)

Experimental: Voltage tomography - Voltage tomography measurements will be made with the SA16 research software and CS19 (1.6.2) software during and/or immediately after electrode insertion during cochlear implantation and at scheduled post-operative clinical visits.


Treatment: Devices: SA16 research software
Software for measurement of voltage tomography intraoperatively.

Treatment: Devices: CS19 (1.6.2)
Software for measurement of voltage tomography post-operatively.

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

Outcomes
Primary outcome [1] 0 0
Voltage tomography data measurement - normative voltage tomography data measurement during and/or immediately after electrode insertion into the cochlea using Surgical Assistant Research Tool (SA16) software
Timepoint [1] 0 0
intraoperatively
Secondary outcome [1] 0 0
Voltage tomography data measurement - normative voltage tomography data measurement at activation (1 month post-surgery), 3 months post-activation and 12 months post-activation using CS19 (1.6.2) software.
Timepoint [1] 0 0
post-operatively at device activation (1 month post surgery), 3 months post-activation and 12 months post-activation

Eligibility
Key inclusion criteria
1. Meet current cochlear implant indications at the implanting centre for a Cochlear
Nucleus CI512, CI422, CI522 or CI532 cochlear implant

2. Aged 18 years and older at the time of implantation.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Recipient of a Nucleus 24 ABI device

2. Medical or psychological conditions that contraindicate undergoing general anaesthesia
or surgery.

3. 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.

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

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
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
Completed
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 Cooperative Research Centre - Carlton
Recruitment hospital [2] 0 0
Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
30002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Hearing Cooperative Research Centre
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

Ethics approval
Ethics application status

Summary
Brief summary
Collection of normative voltage tomography data during and/or immediately after electrode
insertion into the cochlea using Surgical Assistant (SA16) research software and
postoperatively at activation, three and twelve months post-activation with CS19 research
software in adults who are receiving a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear
implant.
Trial website
https://clinicaltrials.gov/show/NCT02852330
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Cowan
Address 0 0
The HEARing CRC
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
Other publications