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Cochlear Hearing LossPIC-22_eCoNNCT04651660

Using Electrocochleography During Cochlear Implantation of the Neuro Zti.

A study testing Neuro Cochlear Implant System in people with Cochlear Hearing Loss and Cochlear Trauma, run by Oticon Medical.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications. First, a novel technique for placing and maintaining the probe in place during the whole insertion will be used. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cochlear Hearing Loss, Cochlear Trauma
What is being tested?
Neuro Cochlear Implant System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2023to Jan 2024
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

  • > or equal 18 years ;
  • Candidate for Neuro Zti EVO cochlear implant system, unilateral or bilateral recipient ;
  • Preoperative residual hearing with audiometric thresholds less or equal than 80 dB at 500 Hz, or higher frequencies

Who cannot join

  • Medical or psychological conditions which contraindicate surgery (e.g middle ear infection, tympanic membrane perforation) ;
  • Patient with a psychological or linguistic inability to understand the information sheet ;
  • Patient under legal protection or deprived of liberty
  • Patient included and participating to another trial.

About this study

Official title: Using Electrocochleography to Guide Insertion of the Electrode Array During Cochlear Implantation of the Neuro Zti (eCoN)

The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications. First, a novel technique for placing and maintaining the probe in place during the whole insertion will be used. Second, a new metric for estimating the eCochG response will be evaluated (eCochG trauma index). The secondary objective is to find other markers of the cochlear trauma insertion associated to eCochG measures. This will be used to evaluate to which extend a traumatic insertion will be deleterious for the patient's post-operative hearing, and ultimately to prevent trauma to the inner ear. Finally, the potential differences in cochlear trauma resulting of the electrode array insertion from two different surgery techniques will be investigated; Either using a manual insertion or using a robotic arm that will drive the insertion automatically.

Read the detailed description

Main study procedures and assessments:

  • Visit 1 (D-30+/-14) INCLUSION: subject information/consent, inclusion/exclusion criteria, CT-scan, Tonal audiometry
  • Visit 2 (D0+/-14) COCHLEAR IMPLANT SURGERY: CT-scan, Intra-op eCochG, eCAP, Impedance
  • Visit 3 (D+30+/-14) FOLLOW-UP 1 MONTH: Tonal audiometry, Impedance, Fitting maps
  • Visit 4 (D+60+/-14) FOLLOW-UP 2 MONTH: Tonal audiometry, Impedance, Fitting maps, Phonemes
  • Visit 5 (D+90+/-14) FOLLOW-UP 3 MONTH: Tonal audiometry, Impedance, Fitting maps, Phonemes
Being tested
Neuro Cochlear Implant System
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.

  • Neuro Cochlear Implant SystemDevice

    Before the mastoidectomy, the ear canal is cleaned, the insert earphone is connected to the Eclipse (Oticon Medical software) preamplifier and placed into the ear canal. The EEG scalp electrodes (active, ground electrode) are placed on the patient's head. After the posterior tympanotomy, the reference electrode (eCochG probe) is placed on the cochlear promontory.

    The CI electrode array will be inserted following one of the two possible techniques while the eCochG will be recording. The surgeon will either manually insert the array using the Oticon Medical stylet and following the surgery guides and recommendations from Oticon Medical or will control the Robotol insertion angle and drive the robotic arm in the same way.

Study groups in NCT04651660
Study groupRoleWhat they receive
Manual InsertionExperimentalThe surgeon will follow a classical surgical procedure for the cochlear implantation, i.e. mastoidectomy to access the temporal bone, posterior tympanotomy to access the cochlea and round window (RW) approach for the CI electrode array insertion. Before opening the RW, the eCochG recording electrode is placed on the cochlear promontory, and placed not to obstruct the surgery. The probe is thus maintained during the whole MANUAL insertion (by the surgeon).
Receives: Device: Neuro Cochlear Implant System
Robotic insertionExperimentalThe surgeon will follow a classical surgical procedure for the cochlear implantation, i.e. mastoidectomy to access the temporal bone, posterior tympanotomy to access the cochlea and round window (RW) approach for the CI electrode array insertion. Before opening the RW, the eCochG recording electrode is placed on the cochlear promontory, and placed not to obstruct the surgery. The probe is thus maintained during the whole ROBOTIC insertion.
Receives: Device: Neuro Cochlear Implant System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation coefficient between the eCochG trauma index (in µV) and the residual hearing (in dB HL).

    The eCochG trauma index correspond to electrophysiological changes of the cochlear response during the CI electrode insertion, and is calculated from the difference between post-insertion and pre-insertion eCochG measure (in µV).

    The hearing loss is calculated from the difference between the post-surgical and pre-surgical hearing thresholds (in dB HL).

    The correspondence is calculated from the correlation coefficient between the eCochG trauma index and the hearing loss.

    It is expected that a potential damage measured by the eCochG during the surgery have affected auditory threshold.

    Measured: Through study completion, an average of 2 years

Secondary outcomes (6)

  1. Significant decrease of eCochG trauma index (in µV) for electrode array insertion performed manually compared to robotic.

    eCochG trauma index (µV) as a result of manual electrode insertion compared with robotic insertion.

    Different behaviors of audiological markers since the cochlea may have suffered from biological cell degradation due to the CI electrode insertion. Allied with cochlear degradation will come increased tissue scar density, subsequently increased resistivity of the biological field to the electrical current. This would imply a cascade effect of electrical and audiological outcomes (higher impedances, higher electrical charges required to evoke a sound or the auditory nerve feedback - eCAP, lower overall performances).

    Measured: Through study completion, average of 2 years

  2. Correlation coefficient between the eCochG trauma index (in µV) and a misplacement of the electrode array inside the cochlea based on CT scan.

    The misplacement will be quantified with the cochlear coverage (in %) and a subjective assessment of the Eschraghi trauma index for exploratory purpose.

    eCochG trauma index (µV) with placement of the CI electrode array in the cochlea (using Pre and Post surgical CT scans).

    Measured: Through study completion, average of 2 years

  3. Correlation coefficient between the eCochG trauma index (in nV) with the electrical charges (in nC) required to elicit eCAP threshold.

    eCochG trauma index (µV) with eCAP thresholds (nC).

    Measured: Through study completion, average of 2 years

  4. Correlation coefficient between the eCochG trauma index (in nV) with impedance measurement (in Ω).

    eCochG trauma index (µV) with CI electrode impedances (Ohm).

    Measured: Through study completion, average of 2 years

  5. Correlation coefficient between the eCochG trauma index (in nV) with fitting map electrical charges (in nC), and slopes of their growth functions.

    eCochG trauma index (µV) with electrical charge (nC) measured on the patient CI fitting map.

    Measured: Through study completion, average of 2 years

  6. Correlation coefficient between the eCochG trauma index (in nV) with scores of phonemes discrimination (%).

    eCochG trauma index (µV) with scores (in %) of phonemes recognition.

    Measured: Through study completion, average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study startJan 2023 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2024 (estimated)

Why it stopped: Devices recall due to hermeticity problems.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04651660
Sponsor's protocol ID
PIC-22
Acronym
PIC-22_eCoN
Status last verified
Mar 2023
First submitted
19 Nov 2020
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Neuro Cochlear Implant System in people with Cochlear Hearing Loss and Cochlear Trauma, run by Oticon Medical.

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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Correlation coefficient between the eCochG trauma index (in µV) and the residual hearing (in dB HL). (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04651660.

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 31 Mar 2023.

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