Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-elutin… (NCT06424262) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
Australia, France, Germany48 participantsStarted 2024-06-17
Plain-language summary
This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or older (at time of consent)
* Clinically established post-linguistic bilateral moderately severe to profound sensorineural hearing loss
* Meets local candidacy criteria for cochlear implantation
* Compromised functional hearing with a hearing aid in the ear to be implanted
* Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
* Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines prior to randomisation
* Candidate is proficient in the language used to assess speech perception performance
* Willing and able to provide written informed consent.
Exclusion Criteria:
* Planned for a partial insertion of the electrode array
* Intra-axial (within the brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted
* Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment
* Active autoimmune disease or active immunosuppressive therapy
* Any of the following in the ear to be implanted within 3 months prior to enrolment: history of prior otologic surgery including grommets, or tympanic membrane perforation
* Previously reported diagnosis of auditory neuropathy, in the ear to be implanted
* Previously reported diagnosis, in the ear to be implanted, of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in the mean monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 6 months post-activation