Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

Conditions
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Implant, Cochlear Hearing Loss

Intervention / Treatment
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* Procedure: cochlear implantation
* Other: computerized tomography (CT) scan
* Other: electromyograph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients eligible for cochlear implantation in CHU Amiens patient more than 18 years old. Exclusion Criteria: malformation or significant antecedent of mastoidectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cochlear implantation|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.|
|Other: computerized tomography (CT) scan|computerized tomography (CT) scan of the facial nerve|
|Other: electromyograph|electromyographic verification of the facial nerve|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cochlear implantation with the ROSA robot surgery time | cochlear implantation with the ROSA robot surgery time | during surgery, day 1 | 
| surgical quality based on material description and surgical technique | surgical quality based on material description and surgical technique | during surgery, day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical quality based on robot precision | surgical quality based on robot precision | during surgery, day 1 | 
| surgical quality based on the cochlear implantation in the cochlea | surgical quality based on the cochlear implantation in the cochlea | during surgery, day 1 | 
| surgical quality based on intraoperative electrophysiological data | surgical quality based on intraoperative electrophysiological data | during surgery, day 1 | 
| surgical quality based on pathological complications | surgical quality based on pathological complications (facial, paralysis, infection, pain) | during surgery and postoperative period (1.5 month after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cochlear implant, robotic, mini-invasive