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
This trial does not accept healthy volunteersQualifiers
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 population
Individuals available from those sites invited to participate in the study consisting of up to 10 subjects implanted with the CI632D and up to 9 subjects with the CI632 in the CIDEX study (NCT04750642)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CI632D
DeviceCI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells
CI632
DeviceCI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
Treatment groups
19 Participants
are divided into 2 treatment groupsGroup A: Experimental: CI632D Investigational Medical Device (IMD)1 intervention
Group B: Active Comparator: CI632 Comparator Device1 intervention
Trial outcomes
Primary outcomes
1
Comparison of Monopolar (MP1+2) Impedance Measurement (kOhms) between groups obtained in the CLTD5759 (NCT04750642) study, and at the 2 through 5 years post-activation routine follow-up visits.
Time frame
5 years post-activationSecondary outcomes
1
Comparison of CI632D and CI632 device-related adverse events between groups from enrolment in this study through 5 years postactivation.
Time frame
5 years post-activation2
Comparison of Four-point Impedance Measurement between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Time frame
5 years post-activation3
Comparison of low-frequency acoustic hearing between groups as measured by pure tone average thresholds over the range 125 through 500 Hz, obtained in the CLTD5759 (NCT04750642) study and from enrolment in this study through 5 years postactivation.
Time frame
5 years post-activation4
Comparison of speech perception in quiet (CNC word scores) for the best unilateral listening condition in the implanted ear between groups obtained in the CLTD5759 (NCT04750642) study, and from enrolment in this study through 5 years postactivation.
Time frame
5 years post-activation Source ClinicalTrials.gov