Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02852330
Registration number
NCT02852330
Ethics application status
Date submitted
3/06/2016
Date registered
2/08/2016
Date last updated
8/11/2022
Titles & IDs
Public title
Intracochlear Potentials: Volta Study
Query!
Scientific title
Intracochlear Potentials: Intraoperative and Post-operative Measurement Clinical Investigation
Query!
Secondary ID [1]
0
0
CLTD5663
Query!
Secondary ID [2]
0
0
CLTD5663
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CLTD5663
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hearing Loss
0
0
Query!
Condition category
Condition code
Ear
0
0
0
0
Query!
Deafness
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Normative Voltage Tomography Data
Query!
Assessment method [1]
0
0
Gather normative voltage tomography data for retrospective analysis. After insertion of the electrode array, TIM measurements will be taken from each subject using the cochlear implant system and Surgical Assistant Research Tool software. A Tip Foldover (TFO) in the software and x-rays will be used to identify any occurrence of a tip foldover.
Query!
Timepoint [1]
0
0
intraoperatively during and/or immediately after electrode insertion into the cochlea, with a measurement time of approximately 10 minutes.
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Basic Science
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/07/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/10/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
20
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
The Hearing Cooperative Research Centre - Carlton
Query!
Recruitment hospital [2]
0
0
Royal Victorian Eye and Ear Hospital - East Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [2]
0
0
30002 - East Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Cochlear
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
The Hearing Cooperative Research Centre
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Royal Victoria Eye and Ear Hospital
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02852330
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Robert Cowan
Query!
Address
0
0
The HEARing CRC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02852330
Download to PDF