Hearing LossNCT02905305
Cochlear Implant With Anti-Inflammatory Agent
A study testing Contour Advance electrode in people with Hearing Loss, run by The Hearing Cooperative Research Centre at 1 site in Australia.
Trial summary
In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Contour Advance electrode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Sep 2013to 15 Mar 2018
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years
- Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age
- Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)
Who cannot join
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including MRI
- Current use of grommets or evidence of tympanic membrane perforation
- Known allergic reaction to dexamethasone or similar medicine
- Diagnosis of Auditory Neuropathy
- Active middle ear infection or history of middle ear infection within past two years
- 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 of the candidate to comply with all investigational requirements
- Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone
In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device.
In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.
- Conditions
- Hearing Loss
- Being tested
- Contour Advance electrode with controlled dose of dexamethasone base, Contour Advance electrode
- Keywords
- cochlear implants, Dexamethasone, combined device
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contour Advance electrode with controlled dose of dexamethasone baseDevice
The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.
Contour Advance electrodeDevice
Standard Contour Advance electrode
| Study group | Role | What they receive |
|---|---|---|
| CA with dexamethasone base | Experimental | Contour Advance electrode with controlled dose of dexamethasone base Receives: Device: Contour Advance electrode with controlled dose of dexamethasone base |
| Contour Advance | Active comparator | Standard Contour Advance electrode array Receives: Device: Contour Advance electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical feedback
Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode
Measured: During surgery
Safety of Combined Device
Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device
Measured: Monitoring over 24 months
Secondary outcomes (2)
Electrode impedance
Measured: Testing over 24 months
Electrically evoked compound action potential (ECAP)
Measured: Testing over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start10 Sep 2013
- Primary completion6 Nov 2017
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hearing Cooperative Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear, Royal Victoria Eye and Ear Hospital, Royal Prince Alfred Hospital, Sydney, Australia, St Vincent's Hospital Melbourne, Westmead Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905305
- Sponsor's protocol ID
- CLTD 5495
- Status last verified
- Jul 2021
- First submitted
- 14 Sep 2016
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Combined Investigational Device: CI4CID With Controlled Dosage of Dexamethasone
- ClinicalTrials.gov ID
- NCT02905305
- Acronym / sponsor ID
- CLTD 5495
- Conditions
- Hearing Loss
- Keywords
- cochlear implants, Dexamethasone, combined device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Hearing Cooperative Research CentreUniversity, hospital or other
- Collaborators
- Cochlear, Royal Victoria Eye and Ear Hospital, Royal Prince Alfred Hospital, Sydney, Australia, St Vincent's Hospital Melbourne, Westmead Hospital
- Study start
- 10 Sep 2013 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
In an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. This study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. This study is a first-time-in-human study of the investigational device.
In the first instance, the aim of the current investigation is to obtain first experience in use of a Combined Device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CA with dexamethasone base | Experimental | Device: Contour Advance electrode with controlled dose of dexamethasone baseContour Advance electrode with controlled dose of dexamethasone base |
| Contour Advance | Active comparator | Device: Contour Advance electrodeStandard Contour Advance electrode array |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years
- Post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age
- Evidence of Pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device)
Key exclusion criteria (8 listed)
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including MRI
- Current use of grommets or evidence of tympanic membrane perforation
- Known allergic reaction to dexamethasone or similar medicine
- Diagnosis of Auditory Neuropathy
- Active middle ear infection or history of middle ear infection within past two years
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 |
|---|---|---|
| Contour Advance electrode with controlled dose of dexamethasone baseThe Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base. | Device | CA with dexamethasone base |
| Contour Advance electrodeStandard Contour Advance electrode | Device | Contour Advance |
Primary outcome
Surgical feedback
Time frame: During surgery
Questionnaire used to obtain surgical feedback from experienced cochlear implant surgeons regarding the electrode design, and ease and effectiveness of surgery, when using the Combined Device as compared to the Contour Advance electrode
Safety of Combined Device
Time frame: Monitoring over 24 months
Monitoring of device related adverse events that occur during the study period, to assess the preliminary safety of the Combined Device
2 secondary outcomes
Electrode impedance
Time frame: Testing over 24 months
Electrically evoked compound action potential (ECAP)
Time frame: Testing over 24 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 6 Jul 2021.
- 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 Contour Advance electrode in people with Hearing Loss, run by The Hearing Cooperative Research Centre at 1 site in Australia.
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 6 Jul 2021. 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 Australia. 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?
Surgical feedback (time frame: During surgery). 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 6 Jul 2021.