Dexamethasone-Eluting Cochlear Implant Electrode (CIDEX)
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|ClinicalTrials.gov Identifier: NCT04450290|
Recruitment Status : Recruiting
First Posted : June 29, 2020
Last Update Posted : July 7, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss, Sensorineural Sensorineural Hearing Loss||Device: CIDEXEL implant||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||First-in-human, single-arm, exploratory, open-label, prospective, longitudinal, monocentric study|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): A First in Human Study|
|Actual Study Start Date :||June 30, 2020|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2021|
Experimental: single arm - treatment
All subjects will be implanted with the investigational device.
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.
- Adverse Events [ Time Frame: 10 months ]Safety profile of the device which will be evaluated through the analysis of adverse events
- IFT (Impedance Field Telemetry) - impedance [ Time Frame: 10 months ]Impedance Field Telemetry and derived values
- Electrically Evoked Compound Action Potential [ Time Frame: 10 months ]Electrically Evoked Compound Action Potential and derived values
- MCL (Maximum Comfortable Loudness) [ Time Frame: 10 months ]Maximum Comfortable Loudness Levels and Thresholds
- THR (Threshold) [ Time Frame: 10 months ]Thresholds
- PTA (Pure Tone Audiometry) Audiometrical values [ Time Frame: 10 months ]Results from PTA assessment
- Hearing Preservation rate [ Time Frame: 10 months ]Rate of Hearing Preservation according to Skarżyński et al.
- HSM (Hochmair-Schulz-Moser Sentence) Test [ Time Frame: 10 months ]Speech test in noise
- Questionnaire [ Time Frame: 10 months ]Surgical feedback questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450290
|Contact: Stefano Morettiniemail@example.com|
|MHH - Medizinische Hochschule Hannover||Recruiting|
|Hannover, Germany, 30625|
|Contact: Thomas Lenarz, Prof. Dr. +49051532|
|Principal Investigator:||Thomas Lenarz, Prof. Prof. h. c. Dr. med.||Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover|