Robotic Assisted Cochlear Implantation Feasibility Study

Study Overview
=================
Brief Summary
-----------------
A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.

Detailed Description
-----------------
A first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.

Official Title
-----------------
Robotic Assisted Cochlear Implantation Feasibility Study

Conditions
-----------------
Sensory Hearing Loss

Intervention / Treatment
-----------------
* Device: Minimally invasive robotic cochlear implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Geographically and physically able to attend scheduled evaluations and follow-up appointments Indicated for cochlear implantation Age 18 years or older Fluent in German or French Sufficient facial recess size ( > 2.5 mm between the facial nerve and chorda tympani) Exclusion Criteria: Pregnancy Anatomical malformation of the middle or inner ear or unusual facial nerve course Lack of compliance with any inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Minimally invasive robotic cochlear implantation with custom device | Device: Minimally invasive robotic cochlear implantation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drilling accuracy | The lateral distance between the center lines of the planned and drilled tunnel positions at the level of the facial nerve measured from medical image data | Image data acquired during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of successfully completed robotic procedures | The number of procedures drilled robotically to the middle ear cavity | The procedure (day 0) | 
| The number of successful cochlear implant electrode array insertions | Number of electrode arrays implanted through the key-hole approach to the middle ear cavity | The procedure (day 0) | 
| Registration accuracy | Fiducial matching error of patient to image registration | The procedure (day 0) | 
| Time of the robotic procedure and its subparts | Total time of the robotic procedure from opening to closing (mean and standard deviation) and of the subprocesses | The procedure (day 0) | 
| Adverse events | Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc | day 0-30 | 
| Blood loss | Intraoperative blood loss (ml) | The procedure (day 0) | 
| Postoperative pain | Pain scale and prescribed pain medication | day 0-30 | 
| Invasiveness of the intervention | Size of incision (mm) | The procedure (day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cochlear implantation, robotics, image guidance