- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06142682
Dexamethasone Eluting Cochlear Implant: a Pivotal Study (CDEX2)
Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): Pivotal Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stefano Morettini, PhD
- Phone Number: +43664607051034
- Email: stefano.morettini@medel.com
Study Locations
-
-
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Bochum, Germany
- HNO-Klinik der Ruhr-Universität Bochum
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Dresden, Germany
- Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
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Frankfurt, Germany
- Universitätsklinikum Frankfurt Klinik für HNO-Heilkunde
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Halle, Germany, 06097
- Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie
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Contact:
- Stefan Plontke, Prof. Dr.
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Hannover, Germany
- HNO-Klinik der Medizinischen Hochschule Hannover
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Tübingen, Germany
- Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
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Würzburg, Germany
- Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen. Die Universitäts-HNO-Klinik Würzburg
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Contact:
- Stephan Hackenberg, Prof. Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Minimum age of eighteen (18) years at time of enrolment. Severe to profound sensorineural hearing loss on the ipsilateral ear (see Figure 4 for the specific audiological criteria).
A functional auditory nerve in the ear to be implanted. Subjects reporting to having used an optimally fit hearing aids for a minimum of three months before the decision that a cochlear implant is the preferential option.
Cochlea anatomy compatible with the insertion of a +FLEX28 electrode array. Compatibility with a soft surgery approach as per clinical practice at the site.
Post-lingual hearing impairment. Subject fulfilling indication criteria for a CI according to the local professional standards, as reported by the implanting surgeon.
General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study and realistic expectations, as deemed appropriate by the implanting surgeon.
Signed and dated informed consent before the start of any study-specific procedure.
Exclusion Criteria:
Lack of compliance with any inclusion criterion. Previously having received a cochlear implant on the ear chosen for placing the IMD.
Evidence of ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or might cause increased risk of infection (e.g. dysplastic cochlea), as confirmed by medical examination and/or as per CT/MRT.
Evidence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull.
Evidence of otosclerosis. Known allergic reaction or intolerance to the materials used in the implant (including medical grade silicone, platinum, iridium, parylene c, DEX).
Known absence of cochlear development or if the cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway.
Evidence of active external or middle ear infection or history of recurrent middle ear infection in the ear to be implanted.
Evidence of perforated tympanic membrane in the ear to be implanted. Patient reporting immunosuppressive therapy or corticosteroids therapy in the 4 weeks before enrolment.
Evidence of concomitant use of medicinal substances that, in the opinion of the investigator, could alter the therapeutic efficacy of dexamethasone.
Unwillingness or inability of the candidate to comply with all investigational requirements.
Evidence of medical contraindications to surgery of the middle and inner ear and anaesthesia.
Additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CIDEXEL
MED-EL Cochlear Implant Mi1250 +FLEX28 DEX (CIDEXEL)
|
cochlear implantation with dexamethasone eluting electrode
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean/median speech perception outcome as % correct of speech test in quiet from prior to implantation to the 6-months follow-up with the CIDEXEL
Time Frame: 6 months visit
|
Speech intelligibility results measured pre-operatively to those measured at the 6-months follow-up.
|
6 months visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IFT
Time Frame: 6 months visit
|
Impedance Field Telemetry data in kOhm per channel
|
6 months visit
|
eCAP
Time Frame: 6 months visit
|
Interphase Gap analysis per electrode in charge units
|
6 months visit
|
Hearing Preservation %
Time Frame: 6 months visit
|
Hearing preservation calculated according to the HEARRING HP scale in %
|
6 months visit
|
HUI 3 (Health Utility Index)
Time Frame: 6 months visit
|
Questionnaire outcomes (scale where dead = 0.00 and perfect health = 1.00)
|
6 months visit
|
NCIQ (Nijmegen Cochlear Implant Questionnaire)
Time Frame: 6 months visit
|
Questionnaire outcomes (Physical, Psychological and Social functioning) score 0-100
|
6 months visit
|
ad Hoc Surgical questionnaire
Time Frame: 6 months visit
|
Questionnaire outcomes descriptively apprised
|
6 months visit
|
OlSa
Time Frame: 6 months visit
|
Speech Intelligibility testing outcomes in dB
|
6 months visit
|
SSQ12 (Speech Spatial Quality of hearing)
Time Frame: 6 months visit
|
Questionnaire outcomes Scores 0-10
|
6 months visit
|
HISQUI (Hearing Implant Sound Quality Index)
Time Frame: 6 months visit
|
Questionnaire outcome: very poor sound quality < 30, poor sound quality 30 - 60, moderate sound quality 60 - 90, good sound quality 90 - 110, very good sound quality 110 - 133
|
6 months visit
|
Wearing time
Time Frame: 6 months visit
|
Audio processor wearing time in min
|
6 months visit
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stefan Plontke, Prof. Dr., Martin-Luther-Universität Halle-Wittenberg, Universitätsklinik und Poliklinik für Hals-Nasen-OhrenHeilkunde, Kopf- und Hals-Chirurgie
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CDEX2_MED-EL_CRD_2021_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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