Cochlear ImplantNCT03515473
Subjective and Objective Results With CI Electrode Types
An observational study of Cochlear Implant, run by Szeged University at 1 site in Hungary.
Trial summary
Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cochlear Implant
- What is being tested?
- cochlear implant
- Type of treatment
- Medical device
- How many people
- 139 participants
- Where
- 1 siteHungary
- Study dates
- 13 Nov 2015to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects implanted with CI532 or CI512 or CI522 in Szeged and St. Pölten between the indicated time frames
Who may be able to join
- successful cochlear implantation with CI532 or CI512 or CI522
- gave informed consent
Who cannot join
- unsuccessful cochlear implantation
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery
Szeged, 6725
About this study
Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.
Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold [ESRT], neural response telemetry threshold [T-NRT] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.
- Conditions
- Cochlear Implant
- Being tested
- cochlear implant
- Keywords
- cochlear implant, CI532, CI512, CI522, electrode array, perimodiolar, electrophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantDevice
cochlear implant surgery
| Study group | Role | What they receive |
|---|---|---|
| CI532 | Patients with CI532 cochlear implant Receives: Device: cochlear implant | |
| CI522 | Patients with CI522 cochlear implant Receives: Device: cochlear implant | |
| CI512 | Patients with CI512 cochlear implant Receives: Device: cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative measurements
Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants.
Measured: 1 day
Intraoperative measurements
Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants
Measured: 1 day
Intraoperative measurements
Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants
Measured: 1 day
Secondary outcomes (3)
Postoperative measurements
Postoperative neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants
Measured: 3 months
Postoperative measurements
Postoperative comfort level (C-level; current unit) with different types of cochlear implants
Measured: 3 months
Postoperative measurements
Power consumption of different types of cochlear implants
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start13 Nov 2015
- Primary completion4 Jun 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, László Rovó, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515473
- Sponsor's protocol ID
- CI-001
- Status last verified
- May 2018
- First submitted
- 15 Jan 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective and Objective Results With CI Electrode Types
- ClinicalTrials.gov ID
- NCT03515473
- Acronym / sponsor ID
- CI-001
- Conditions
- Cochlear Implant
- Keywords
- cochlear implant, CI532, CI512, CI522, electrode array, perimodiolar, electrophysiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 4 Jun 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.
Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold [ESRT], neural response telemetry threshold [T-NRT] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CI532 | – | Device: cochlear implantPatients with CI532 cochlear implant |
| CI522 | – | Device: cochlear implantPatients with CI522 cochlear implant |
| CI512 | – | Device: cochlear implantPatients with CI512 cochlear implant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects implanted with CI532 or CI512 or CI522 in Szeged and St. Pölten between the indicated time frames
Key inclusion criteria (2 listed)
- successful cochlear implantation with CI532 or CI512 or CI522
- gave informed consent
Key exclusion criteria (1 listed)
- unsuccessful cochlear implantation
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 implantcochlear implant surgery | Device | CI512, CI522, CI532 |
Primary outcome
Intraoperative measurements
Time frame: 1 day
Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants.
Intraoperative measurements
Time frame: 1 day
Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants
Intraoperative measurements
Time frame: 1 day
Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants
3 secondary outcomes
Postoperative measurements
Time frame: 3 months
Postoperative measurements
Time frame: 3 months
Postoperative measurements
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implant
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Mi2000 TICI - Post-market Implantation Study
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Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
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Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
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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?
An observational study of Cochlear Implant, run by Szeged University at 1 site in Hungary.
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 2 inclusion and 1 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 3 May 2018. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intraoperative measurements (time frame: 1 day). The study lists 3 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 3 May 2018.