Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

  • STATUS
    Recruiting
  • End date
    Oct 26, 2021
  • participants needed
    10
  • sponsor
    Centre Hospitalier Universitaire, Amiens
Updated on 26 January 2021

Summary

Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.

Description

The ROSA robot coupled to the O-Arm scanner will guide the milling to the round window, whose path has been previously modeled, with the identification of the facial nerve. Milling will be done in 2 stages with a CT (computerised tomography scan) and electromyographic verification of the facial nerve. The insertion of the implant will be performed manually under endoscopic control. The preoperative and postoperative course of the patient will be identical.

Details
Condition Sensorineural hearing loss, Hearing Loss, Auditory Loss and Deafness, implant, Hearing Impairment, implant procedure, surgical implantation
Treatment cochlear implantation, computerized tomography (CT) scan, electromyograph
Clinical Study IdentifierNCT04048239
SponsorCentre Hospitalier Universitaire, Amiens
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: implant or Hearing Loss or implant procedure or surgical implantation or Hearing Impairment or Sensorineural hearing loss or Auditory Loss and Deafnes...?
Do you have any of these conditions: Hearing Loss or surgical implantation or implant procedure or Hearing Impairment or Sensorineural hearing loss or implant or Auditory Loss and Deafnes...?
Do you have any of these conditions: surgical implantation or implant or Sensorineural hearing loss or Auditory Loss and Deafness or implant procedure or Hearing Loss or Hearing Impairmen...?
patients eligible for cochlear implantation in CHU Amiens
patient more than 18 years old

Exclusion Criteria

malformation or significant antecedent of mastoidectomy
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