Clinical Trial

Dexamethasone Eluting Cochlear Implant: a Pivotal Study

Study acronym: CDEX2
Recruiting
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Record status
This record was last updated August 12, 2025 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The newly developed MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL) incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma. The aim of this clinical investigation is to obtain confirmatory data concerning safety and performances of the investigational device in the clinical population.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-11-16; most recent amendment 2025-08-11.
Status change: Not Yet Recruiting → Recruiting 2024-09-10
Trial Details
NCT Number NCT06142682
Lead Sponsor MED-EL Elektromedizinische Geräte GesmbH
Conditions Cochlear Implant
Enrollment 60 participants
Start Date 2024-09-02
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-12