Hearing Loss, SensorineuralCIDEXNCT04450290
Dexamethasone-Eluting Cochlear Implant Electrode
A study testing CIDEXEL implant in people with Hearing Loss, Sensorineural and Sensorineural Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Sensorineural Hearing Loss
- What is being tested?
- CIDEXEL implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jun 2020to 5 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age of eighteen (18) years at time of enrolment.
- Severe to profound sensorineural hearing loss on the ipsilateral ear.
- 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 (CI) 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.
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- 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.
Who cannot join
- Lack of compliance with any inclusion criterion.
- Previously having received a cochlear implant on the ear chosen for placing the IMD (Investigational Medical Device).
- 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 (Computed Tomography/Magnetic Resonance Tomography).
- 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, dexamethasone).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): A First in Human Study
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.
Read the 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.
- Being tested
- CIDEXEL implant
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIDEXEL implantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| single arm - treatment | Experimental | All subjects will be implanted with the investigational device. Receives: Device: CIDEXEL implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Safety profile of the device which will be evaluated through the analysis of adverse events
Measured: 10 months
Secondary outcomes (8)
IFT (Impedance Field Telemetry) - impedance
Impedance Field Telemetry and derived values
Measured: 10 months
Electrically Evoked Compound Action Potential
Electrically Evoked Compound Action Potential and derived values
Measured: 10 months
MCL (Maximum Comfortable Loudness)
Maximum Comfortable Loudness Levels and Thresholds
Measured: 10 months
THR (Threshold)
Thresholds
Measured: 10 months
PTA (Pure Tone Audiometry) Audiometrical values
Results from PTA assessment
Measured: 10 months
Hearing Preservation rate
Rate of Hearing Preservation according to Skarżyński et al.
Measured: 10 months
HSM (Hochmair-Schulz-Moser Sentence) Test
Speech test in noise
Measured: 10 months
Questionnaire
Surgical feedback questionnaire
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start30 Jun 2020
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First-in-human, single-arm, exploratory, open-label, prospective, longitudinal, monocentric study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Lenarz, Prof. Prof. h. c. Dr. med., Principal investigator, Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450290
- Sponsor's protocol ID
- MED-EL_CRD_2014_02
- Acronym
- CIDEX
- Status last verified
- May 2022
- First submitted
- 16 Jun 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone-Eluting Cochlear Implant Electrode (CIDEXEL): A First in Human Study
- ClinicalTrials.gov ID
- NCT04450290
- Acronym / sponsor ID
- CIDEX / MED-EL_CRD_2014_02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First-in-human, single-arm, exploratory, open-label, prospective, longitudinal, monocentric study
| Arm | Type | Receives |
|---|---|---|
| single arm - treatment | Experimental | Device: CIDEXEL implantAll subjects will be implanted with the investigational device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Minimum age of eighteen (18) years at time of enrolment.
- Severe to profound sensorineural hearing loss on the ipsilateral ear.
- 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 (CI) is the preferential option.
- Cochlea anatomy compatible with the insertion of a +FLEX28 electrode array.
Key exclusion criteria (14 listed)
- Lack of compliance with any inclusion criterion.
- Previously having received a cochlear implant on the ear chosen for placing the IMD (Investigational Medical Device).
- 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 (Computed Tomography/Magnetic Resonance Tomography).
- Evidence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull.
- Evidence of otosclerosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIDEXEL implantThe 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. | Device | single arm - treatment |
Primary outcome
Adverse Events
Time frame: 10 months
Safety profile of the device which will be evaluated through the analysis of adverse events
8 secondary outcomes
IFT (Impedance Field Telemetry) - impedance
Time frame: 10 months
Electrically Evoked Compound Action Potential
Time frame: 10 months
MCL (Maximum Comfortable Loudness)
Time frame: 10 months
THR (Threshold)
Time frame: 10 months
PTA (Pure Tone Audiometry) Audiometrical values
Time frame: 10 months
Hearing Preservation rate
Time frame: 10 months
HSM (Hochmair-Schulz-Moser Sentence) Test
Time frame: 10 months
Questionnaire
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Lenarz, Prof. Prof. h. c. Dr. med. principal investigator
Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CIDEXEL implant in people with Hearing Loss, Sensorineural and Sensorineural Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.