Clinical trial NCT04651660: Using Electrocochleography During Cochlear Implantation of the Neuro Zti.
Official title: Using Electrocochleography to Guide Insertion of the Electrode Array During Cochlear Implantation of the Neuro Zti (eCoN)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cochlear Hearing Loss
Cochlear Trauma
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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

Eligibility criteria: Inclusion Criteria:

* \> 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Correlation coefficient between the eCochG trauma index (in µV) and the residual hearing (in dB HL).
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Significant decrease of eCochG trauma index (in µV) for electrode array insertion performed manually compared to robotic.
timeFrame: Through study completion, average of 2 years
measure: Correlation coefficient between the eCochG trauma index (in µV) and a misplacement of the electrode array inside the cochlea based on CT scan.
timeFrame: Through study completion, average of 2 years
measure: Correlation coefficient between the eCochG trauma index (in nV) with the electrical charges (in nC) required to elicit eCAP threshold.
timeFrame: Through study completion, average of 2 years
measure: Correlation coefficient between the eCochG trauma index (in nV) with impedance measurement (in Ω).
timeFrame: Through study completion, average of 2 years
measure: Correlation coefficient between the eCochG trauma index (in nV) with fitting map electrical charges (in nC), and slopes of their growth functions.
timeFrame: Through study completion, average of 2 years
measure: Correlation coefficient between the eCochG trauma index (in nV) with scores of phonemes discrimination (%).
timeFrame: Through study completion, average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Pitié-Salpêtrière (Paris)
name: Yann YN Nguyen
role: PRINCIPAL_INVESTIGATOR
References: