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Clinical Trial

Dexamethasone Eluting Cochlear Implant: a Pivotal Study

NCT: NCT06142682 · COMPLETED

NCT IDNCT06142682
StatusCOMPLETED
Start Date2024-09-02
Completion2026-08-18
SponsorMED-EL Elektromedizinische Geräte GesmbH (INDUSTRY)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is Dexamethasone Eluting Cochlear Implant: a Pivotal Study?

Dexamethasone Eluting Cochlear Implant: a Pivotal Study is a clinical trial registered under NCT06142682. Current status: COMPLETED.

What is the status of NCT06142682?

The current status of NCT06142682 (Dexamethasone Eluting Cochlear Implant: a Pivotal Study) is: COMPLETED.

When did Dexamethasone Eluting Cochlear Implant: a Pivotal Study start?

Dexamethasone Eluting Cochlear Implant: a Pivotal Study started on 2024-09-02.

Related Devices

PMA P000025Implant, cochlearMed-El Corp.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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