The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

Study Overview
=================
Brief Summary
-----------------
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.

Official Title
-----------------
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

Conditions
-----------------
Sensorineural Hearing Loss

Intervention / Treatment
-----------------
* Device: HEARO
* Device: OTOPLAN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant. Exclusion Criteria: Age under 18 years Pregnancy Distance of the planned trajectory to the facial nerve is < 0.4mm Distance of the planned trajectory to the chorda tympani is < 0.3mm Vulnerability Invalid or withdrawn informed consent

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
Interventional Model Description: SIngle arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARCI25<br>Robot assited Cochlear implant surgery. | Device: HEARO<br>* Robotic system for otological procedures<br>* Other names: HEARO procedures;Device: OTOPLAN<br>* Otological surgical planning software<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy) | The ratio of the number of the procedures in which it was possible to insert the electrode inside the cochlea through the direct cochlear access compared to the number of procedures in which the insertion through the direct cochlea access was not possible will be calculated. Aborted or converted procedures count as procedure in which insertion through the direct cochlea access was not possible. The results will be expressed in relative numbers (n of 25) and in percentage (%). | Image data aquired during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrode array insertion depth (Efficacy) | The electrode insertion depth will be measured in the post-operative image. (Degrees °) | The procedure (day 0) | 
| Number of correctlly inserted electrode contact (Efficacy) | The number of inserted electrode contacts into the inner ear will be counted in the post-operative image. (Number n) number of contacts inserted (n) | The procedure (day 0) | 
| Insertion depth prediction accuracy (Efficacy) | The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth. (Degrees °) | The procedure (day 0) | 
| Absolute angular accuracy of the drilled tunnel access | The absolute in-plane and out-plane accuracy of the drilled tunnel is measured as the angular deviation between the planned and the actual angles. | The procedure (day 0) | 
| Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety) | The absolute lateral accuracy of the drilled tunnel to the facial nerve and chorda tympani is measured as the difference between the planned and the actual distance. (mm) | The procedure (day 0) | 
| Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety) | The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned and actual target position. (mm) | The procedure (day 0) | 
| Evaluation of the automatic landmark detection (Performance) | The relative ratio of the automatically identified landmarks by OTOPLAN that were not manually adjusted by the surgeon. The intended landmarks are: Middle ear cavity breakthrough Bony overhang lateral wall Bony overhang medial wall The absolute distance between the new position of the adjusted landmark to the position of the automatically identified landmark will be evaluated. (Number n) | The procedure (day 0) |