Hearing LossNCT02677220
Implantation With the Nucleus CI532 Cochlear Implant in Adults
A study testing CI532 cochlear implant in people with Hearing Loss, run by Cochlear at 1 site in United States.
Trial summary
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant. The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath. 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?
- CI532 cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2016to 23 Aug 2017
- 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
- Meet current cochlear implant criteria at the implanting center
- 18 years or older with bilateral sensorineural hearing loss
- Limited benefit from appropriate binaural hearing aids
- Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies
- Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted
- Fluent speaker in the language used to assess clinical performance
Who cannot join
- Evidence of hearing loss prior to age 5
- Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz
- Simultaneous bilateral implantation prior to the study
- Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery
- Cochlear anomaly that might prevent complete insertion of the electrode array
- Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway
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- Active middle ear infection
- Tympanic membrane perforation
- Unrealistic expectations
- Unwillingness or inability co comply with all investigational requirements
- Patients with existing cerebral shunts or drains
- Recurrent episodes of bacterial meningitis
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant.
The 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
- 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.
CI532 cochlear implantDevice
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Experimental | Subjects to be implanted with the CI532 cochlear implant in one ear Receives: Device: CI532 cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
AzBio Sentence Recognition in Noise
The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct.
Measured: 3 months post-activation
Secondary outcomes (2)
Glasgow Benefit Inventory
The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.
Measured: 6 months post-activation
Speech, Spatial, and Qualities of Hearing Scale
The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).
Measured: 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 posted9 Feb 2016 (estimated)
- Study start11 May 2016
- Primary completion23 Aug 2017
- Study completion23 Aug 2017
Why it stopped: No enrolled subjects
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.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677220
- Sponsor's protocol ID
- CAM5631
- Status last verified
- Feb 2019
- First submitted
- 3 Feb 2016
- Last updated
- 12 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation With the Nucleus CI532 Cochlear Implant in Adults
- ClinicalTrials.gov ID
- NCT02677220
- Acronym / sponsor ID
- CAM5631
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No enrolled subjects
- Enrolment
- 1 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health
- Study start
- 11 May 2016 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 12 Mar 2019
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.
The 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 |
|---|---|---|
| Surgical | Experimental | Device: CI532 cochlear implantSubjects to be implanted with the CI532 cochlear implant in one ear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet current cochlear implant criteria at the implanting center
- 18 years or older with bilateral sensorineural hearing loss
- Limited benefit from appropriate binaural hearing aids
- Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies
- Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted
Key exclusion criteria (12 listed)
- Evidence of hearing loss prior to age 5
- Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz
- Simultaneous bilateral implantation prior to the study
- Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery
- Cochlear anomaly that might prevent complete insertion of the electrode array
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 |
|---|---|---|
| CI532 cochlear implant | Device | Surgical |
Primary outcome
AzBio Sentence Recognition in Noise
Time frame: 3 months post-activation
The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct.
2 secondary outcomes
Glasgow Benefit Inventory
Time frame: 6 months post-activation
Speech, Spatial, and Qualities of Hearing Scale
Time frame: 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 12 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CI532 cochlear implant in people with Hearing Loss, run by Cochlear at 1 site in United States.
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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 12 Mar 2019). 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?
AzBio Sentence Recognition in Noise (time frame: 3 months post-activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2019.