Dexamethasone Eluting Cochlear Implant: a Pivotal Study — CDEX2  

Cochlear Implant Clinical Trial

Official title: Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): Pivotal Study

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

The Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL) is the Investigational Medical Device (IMD) under investigation. MED-EL CI systems consist of an implantable part (i.e. CIDEXEL), external components (i.e. technically compatible audio/speech processor and its accessories) and software that controls and powers the implant. The IMD CIDEXEL will be the implantable part of this new MED-EL CI System and shall only be used together with technically compatible MED-EL external components.

None of the components mentioned above incorporates, as an integral part transplants or tissues or cells of human or animal origin. No products incorporating or derived from tissues or cells of human or animal origin were used during its manufacturing.

• Primary Objective

The primary objective of this clinical investigation is to confirm the clinical performance of the CIDEXEL by comparing Speech intelligibility results measured pre-operatively to those measured at the 6-months follow-up.

For this clinical investigation to be successful, mean speech test results at the 6-months visit shall be superior to the mean speech test results obtained pre-operatively. (Monosyllables)

• Secondary Objectives

The secondary objectives of this clinical investigation are to measure:

• Impedance Field Telemetry (IFT) values and derived measures

• Fitting Maps reiteration appraisal

• Electrically evoked Compound Action Potential (eCAP) and derived measures

• Unaided audiograms obtained pre- and post-operatively

• Hearing Preservation (HP) %

• The improvement in generic quality of life (measured by the Health Utilities Index (HUI2&3)) pre- to the 6-months visit

• The improvement in disease specific quality of life (measured by the Nijmegen Cochlear Implant Questionnaire (NCIQ)) pre- to the 6-months visit

• Surgical Usability and satisfaction (Ad Hoc questionnaire for the surgeons )

• Sentence test in noise results across the tested intervals (OlSa)

• Speech, spatial and quality of hearing across the tested intervals (Speech, Spatial and Qualities of hearing scale (SSQ12))

• Sound quality over time (Hearing Implant Sound Quality Index (HISQUI))

• Wearing time (data Logging)

• Safety Objective

The purpose of this clinical investigation is to establish and verify the clinical safety of the CIDEXEL. To confirm the safety profile of the device which will be evaluated through the analysis of adverse events during the follow-up period. For the study to be considered a success, the results of the adverse event analysis shall never cause an unbalanced risk vs. benefit assessment biased towards the former. ;

Related Conditions & MeSH terms

• Cochlear Implant

• NCT number: NCT06142682
• Study type: Interventional
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: Stefano Morettini, PhD
• Phone: +43664607051034
• Email: stefano.morettini@medel.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Completion date: December 31, 2024