Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure

  • STATUS
    Recruiting
  • End date
    Mar 15, 2023
  • participants needed
    10
  • sponsor
    MED-EL Elektromedizinische Geräte GesmbH
Updated on 30 December 2021

Summary

The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.

Description

The cochlear implant (CI) is a neural prothesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation surgery aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to initially create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of large portions of the mastoid bone through a wide mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation.

To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place.

This study primarily aims to explore the efficacy of the HEARO robotic cochlear implantation surgery.

Primary Objective

The primary objective of this study is to:

• explore the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.

Secondary Objectives

The secondary objectives of this study are to:

  • explore the safety of a minimally invasive direct cochlear access via the HEARO procedure.
  • exploratively evaluate the electrode array insertion outcomes through the direct tunnel access.

Details
Condition Sensorineural Hearing Loss, Bilateral
Treatment Robotic Surgery
Clinical Study IdentifierNCT04777565
SponsorMED-EL Elektromedizinische Geräte GesmbH
Last Modified on30 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age under 18 years
Pregnancy
Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT scan
Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening CT scan
A safe inner ear access cannot be planned for preservation of RW membrane and cochlear structures
Individuals where image guidance or robotic procedures are not indicated
Individuals who have known allergy to components of the cochlear implant
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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