Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCochlear
About this trial
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
Eligibility criteria
Qualifiers
Subjects who completed study obligations of the CLTD5759 CI-DEX study and enrolled at a site selected for participation.
Subjects implanted with a CI632D or a CI632 cochlear implant under the CLTD5759 (NCT04750642).
Willing and able to provide written informed consent.
Disqualifiers
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to participation as determined by the Investigator.
Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
Unable or unwilling to comply with all the requirements of the clinical investigation as determined by the Investigator.
Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Trial design
Treatments tested in this trial
- CI632D
- CI632
Treatment groups
19 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov