NCT04450290

Dexamethasone-Eluting Cochlear Implant Electrode

Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): A First in Human Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A newly developed MED-EL Cochlear Implant 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 a first experience in use of the investigational device in the adult clinical population, and to initially assess tools, techniques and performance outcome measures that may be considered in future clinical studies of similar devices.

Detailed description

The principal objective of this study is to exploratively investigate 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. The secondary objectives of this study aim at investigating the usefulness of possible outcome measures in evaluating the performance of the device.

Conditions

• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Interventions

Type	Name	Description
DEVICE	CIDEXEL implant	The newly developed MED-EL Cochlear Implant 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.

Timeline

• Start date: 2020-06-30
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2020-06-29
• Last updated: 2022-06-01

Locations

1 site across 1 country: Germany