Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques

Study Overview
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Brief Summary
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To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.

Detailed Description
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Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults. Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation. Validate the system and procedure safety mechanisms. Collect required data for validation of safety algorithms and procedure workflow optimisation. Validate the HEARO system.

Official Title
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Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques

Conditions
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Sensorineural Hearing Loss

Intervention / Treatment
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* Device: HEARO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from profound sensorineural deafness requiring a Cochlear implant Exclusion Criteria: Age under 18 years Pregnant women Anatomical anomalies of temporal bone Chronic otitis media with or without cholesteatoma

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive robotic cochlear implantation with HEARO<br> | Device: HEARO<br>* Robotic system for otological procedures<br>* Other names: HEARO procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel. |  | Image data aquired during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of completed middle ear access |  | The procedure (day 0) | 
| Number of completed inner ear access |  | The procedure (day 0) | 
| Accuracy of the drilled trajectory |  | Image data aquired during the procedure | 
| Sensitivity and specificity of facial nerve monitoring |  | The procedure (day 0) | 
| Measurement of the insertion angle | Measurement of the insertion depth of the electrode into the Cochlea | Image data aquired during the procedure | 
| Number of tip fold-overs |  | The procedure (day 0) | 
| Number of Scala deviations |  | The procedure (day 0) | 
| Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection |  | day 0-30 | 
| Time of procedure |  | The procedure (day 0) | 
| Volume of tissue removed |  | Image data aquired during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot, Image guidance, Cochlear implantation, navigation, HEARO procedure, sensorineural hearing loss, inner ear access