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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02392403




Registration number
NCT02392403
Ethics application status
Date submitted
13/03/2015
Date registered
19/03/2015
Date last updated
1/11/2018

Titles & IDs
Public title
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
Scientific title
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
Secondary ID [1] 0 0
CLTD5446
Universal Trial Number (UTN)
Trial acronym
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 - Nucleus CI532 cochlear implant

Experimental: Nucleus CI532 cochlear implant -


Treatment: Devices: Nucleus CI532 cochlear implant


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

Outcomes
Primary outcome [1] 0 0
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan - The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.
Timepoint [1] 0 0
up to one month post-surgery
Secondary outcome [1] 0 0
Array Proximity to the Modiolus Measured Using the Wrapping Factor - The ratio of the active array length and the corresponding lateral wall length
Timepoint [1] 0 0
up to one month post-surgery
Secondary outcome [2] 0 0
Surgeon Questionnaire on Implant Surgery - To collect experiences using the CI532. At each surgery, the surgeon was asked whether "overall the CI532 was easy to handle and the EA32 easy to insert". We counted the number of surgeons who strongly agreed or who agreed.
Timepoint [2] 0 0
at time of surgery
Secondary outcome [3] 0 0
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months - Change in percent correct speech recognition test scores for implant ear alone and best aided
Timepoint [3] 0 0
baseline and 6 months post activation
Secondary outcome [4] 0 0
Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire - The Glasgow Benefit Inventory is a single time point measure of patient reported benefit.
A score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100.
Timepoint [4] 0 0
6 months post activation
Secondary outcome [5] 0 0
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months - Rating scale. 0=worst; 10=best
Timepoint [5] 0 0
baseline and 6 months post activation
Secondary outcome [6] 0 0
Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months - We report only the change for the 500 Hz frequency.
Timepoint [6] 0 0
baseline and 6 months post activation
Secondary outcome [7] 0 0
Number of Adverse Events at Surgery
Timepoint [7] 0 0
at time of surgery
Secondary outcome [8] 0 0
Number of Adverse Events Post Surgery to 6 Months Post-activation
Timepoint [8] 0 0
post surgery to 6 months post-activation

Eligibility
Key inclusion criteria
- Eighteen years of age or older at the time of implantation

- Conventional candidate for cochlear implantation with a perimodiolar electrode array
according to local criteria (excepting the exclusion criteria that follow)

- Native speaker in the local language used to assess clinical performance
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Evidence of hearing loss prior to 5 years of age

- Prior cochlear implantation; i.e. having a cochlear implant in the contralateral ear,
or previously implanted in either ear

- Medical or psychological conditions that contraindicate undergoing general anaesthesia
or surgery

- 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

- Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or
central auditory pathway

- Active middle-ear infection

- Tympanic membrane perforation

- 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

- Unwillingness or inability of the candidate to comply with all investigational
requirements such as undergoing a post-operative digital volume tomography/ConeBeam
scan

- Patients with existing Cerebral Spinal Fluid shunts or drains, existing perilymph
fistula, skull fracture or Cerebral Spinal Fluid leak

- Patients with recurrent episodes of bacterial meningitis

- Pregnancy or breast-feeding

- Known allergies to components of the implant

- Wearing other active implants with known interference with cochlear implants

Study design
Purpose of the study
Treatment
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 CRC - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Midi-Pyrénées
Country [2] 0 0
Germany
State/province [2] 0 0
Baden-Württemberg
Country [3] 0 0
Germany
State/province [3] 0 0
Bavaria
Country [4] 0 0
Germany
State/province [4] 0 0
Hessen
Country [5] 0 0
Germany
State/province [5] 0 0
Niedersachsen
Country [6] 0 0
Germany
State/province [6] 0 0
Schleswig-Holstein
Country [7] 0 0
Spain
State/province [7] 0 0
Gran Canaria

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cochlear
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to investigate the clinical benefit for patients implanted with the
Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode
design.

Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the
cochlea through a straightening sheath.
Trial website
https://clinicaltrials.gov/show/NCT02392403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris J James, PhD
Address 0 0
Cochlear
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