Sensorineural Hearing Loss, BilateralNCT02755935
CI532 - Early Experience Study
A study testing Cochlear Nucleus CI532 in people with Sensorineural Hearing Loss, Bilateral, run by Cochlear at 6 sites in United States.
Trial summary
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array. Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Sensorineural Hearing Loss, Bilateral
- What is being tested?
- Cochlear Nucleus CI532
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2016to Sep 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 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
- Post-linguistically deafened
- Ability to complete age appropriate testing
Who cannot join
- Previous cochlear implantation in the ear to be implanted
- Pre-linguistically deafened (onset of hearing loss at less than two years of age)
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Diagnosis of retro-cochlear pathology
- Diagnosis of auditory neuropathy
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
- Unwillingness or inability to comply with all investigational requirements
- Additional cognitive handicaps that would prevent participation on all study requirements
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The University of Michigan
Ann Arbor, Michigan, 48108
Center for Hearing and Balance
Chesterfield, Missouri, 63017
Dallas Ear Institute
Dallas, Texas, 75230
University of Iowa
Iowa City, Iowa, 52242
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
NorthShore University
Skokie, Illinois, 60201
About this study
Official title: Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
Read the detailed description
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Being tested
- Cochlear Nucleus CI532
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear Nucleus CI532Device
cochlear implantation
| Study group | Role | What they receive |
|---|---|---|
| Implanted | Experimental | Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant Receives: Device: Cochlear Nucleus CI532 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.
Measured: 3 months postactivation of the sound processor
Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise
Measured: 3 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 posted29 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionSep 2017
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 Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755935
- Sponsor's protocol ID
- CAM5660
- Status last verified
- Jan 2018
- First submitted
- 19 Apr 2016
- Last updated
- 20 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
- ClinicalTrials.gov ID
- NCT02755935
- Acronym / sponsor ID
- CAM5660
- Conditions
- Sensorineural Hearing Loss, Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 22 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
Detailed description
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted | Experimental | Device: Cochlear Nucleus CI532Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
- Post-linguistically deafened
- Ability to complete age appropriate testing
Key exclusion criteria (8 listed)
- Previous cochlear implantation in the ear to be implanted
- Pre-linguistically deafened (onset of hearing loss at less than two years of age)
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Diagnosis of retro-cochlear pathology
- Diagnosis of auditory neuropathy
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 |
|---|---|---|
| Cochlear Nucleus CI532cochlear implantation | Device | Implanted |
Primary outcome
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
Time frame: 3 months postactivation of the sound processor
Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.
Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear
Time frame: 3 months post-activation
unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Nucleus CI532 in people with Sensorineural Hearing Loss, Bilateral, run by Cochlear at 6 sites 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 3 inclusion and 8 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 22 Feb 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?
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear (time frame: 3 months postactivation of the sound processor). The study lists 2 primary outcomes in all. 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 20 Mar 2018.