Hearing LossNCT02392403
Clinical Investigation of the Nucleus® CI532 Cochlear Implant
A study testing Nucleus CI532 cochlear implant in people with Hearing Loss, run by Cochlear at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Nucleus CI532 cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Apr 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Germany5 sites
Ear, Nose and Throat Department, Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Klinikum der J. W. Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, 60590
Ear, Nose and Throat Department, University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Ear, Nose and Throat Department, Medizinische Hochschule
Hanover, Lower Saxony, 30625
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, 24105
France1 site
Service d' ORL et d'Otoneurochirurgie, CHU Toulouse Purpan
Toulouse, Midi-Pyrénées, 31059
Spain1 site
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas, Gran Canaria, 35016
About this study
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.
- Conditions
- Hearing Loss
- Being tested
- Nucleus CI532 cochlear implant
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleus CI532 cochlear implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Nucleus CI532 cochlear implant | Experimental | Not described Receives: Device: Nucleus CI532 cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one month post-surgery
Secondary outcomes (8)
Array Proximity to the Modiolus Measured Using the Wrapping Factor
The ratio of the active array length and the corresponding lateral wall length
Measured: up to one month post-surgery
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.
Measured: at time of surgery
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
Measured: baseline and 6 months post activation
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.
Measured: 6 months post activation
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months
Rating scale. 0=worst; 10=best
Measured: baseline and 6 months post activation
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.
Measured: baseline and 6 months post activation
Number of Adverse Events at Surgery
Measured: at time of surgery
Number of Adverse Events Post Surgery to 6 Months Post-activation
Measured: post surgery to 6 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris J James, PhD, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392403
- Sponsor's protocol ID
- CLTD5446
- Status last verified
- Jul 2017
- First submitted
- 13 Mar 2015
- Last updated
- 1 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hey M, Wesarg T, Mewes A, Helbig S, Hornung J, Lenarz T, Briggs R, Marx M, Ramos A, Stover T, Escude B, James CJ, Aschendorff A. Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. Cochlear Implants Int. 2019 Mar;20(2):80-90. doi: 10.1080/14670100.2018.1544684. Epub 2018 Nov 22.
PubMed 30465637
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Nucleus® CI532 Cochlear Implant
- ClinicalTrials.gov ID
- NCT02392403
- Acronym / sponsor ID
- CLTD5446
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 1 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nucleus CI532 cochlear implant | Experimental | Device: Nucleus CI532 cochlear implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nucleus CI532 cochlear implant | Device | Nucleus CI532 cochlear implant |
Primary outcome
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan
Time frame: up to one month post-surgery
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.
8 secondary outcomes
Array Proximity to the Modiolus Measured Using the Wrapping Factor
Time frame: up to one month post-surgery
Surgeon Questionnaire on Implant Surgery
Time frame: at time of surgery
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months
Time frame: baseline and 6 months post activation
Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire
Time frame: 6 months post activation
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months
Time frame: baseline and 6 months post activation
Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months
Time frame: baseline and 6 months post activation
Number of Adverse Events at Surgery
Time frame: at time of surgery
Number of Adverse Events Post Surgery to 6 Months Post-activation
Time frame: post surgery to 6 months post-activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30465637Hey M, Wesarg T, Mewes A, Helbig S, Hornung J, Lenarz T, Briggs R, Marx M, Ramos A, Stover T, Escude B, James CJ, Aschendorff A. Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. Cochlear Implants Int. 2019 Mar;20(2):80-90. doi: 10.1080/14670100.2018.1544684. Epub 2018 Nov 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris J James, PhD study director
Cochlear
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nucleus CI532 cochlear implant in people with Hearing Loss, run by Cochlear at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Australia, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan (time frame: up to one month post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.