At a glance
ClinicalIndex Comparison RecordN/ACompleted· 42 enrolled
Drug / intervention
CI632D +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cochlear Implant With Dexamethasone Eluting Electrode Array (The CI-DEX Study): Pivotal Study
In Brief
A clinical study evaluating CI632D and CI632 for Sensorineural Hearing Loss and Bilateral Hearing Loss. Completed, enrolled 42 participants across 8 sites in 3 countries.
Detailed Summary
An evaluation of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSensorineural Hearing Loss, Bilateral Hearing Loss
CountriesAustralia, New Zealand, United States
CollaboratorsNAMSA, Avania, Vanderbilt University
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartOct 2021
Primary CompletionJul 2023
Study CompletionFeb 2024
TodayJul 2026
First PostedFeb 11, 2021
Enrollment StartOct 4, 2021
Primary CompletionJul 7, 2023
Study CompletionFeb 23, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.4 years ago
Interventions
CI632Ddevice
CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
CI632device
CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone