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Using Electrocochleography During Cochlear Implantation of the Neuro Zti.

NCT04651660 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-31

No results posted yet for this study

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.

Conditions

  • Cochlear Hearing Loss
  • Cochlear Trauma

Interventions

DEVICE

Neuro Cochlear Implant System

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.

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Yann YN Nguyen · Hôpital Pitié-Salpêtrière (Paris)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-01-31
Completion
2024-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04651660 on ClinicalTrials.gov