Sensory Hearing Loss
Conditions
Keywords
cochlear implantation, robotics, image guidance
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.
Interventions
DEVICEMinimally invasive robotic cochlear implantation
Sponsors
University of Bern
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drilling accuracy | Image data acquired during the procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of successful cochlear implant electrode array insertions | The procedure (day 0) | Number of electrode arrays implanted through the key-hole approach to the middle ear cavity |
| Registration accuracy | The procedure (day 0) | Fiducial matching error of patient to image registration |
| Time of the robotic procedure and its subparts | The procedure (day 0) | Total time of the robotic procedure from opening to closing (mean and standard deviation) and of the subprocesses |
| Number of successfully completed robotic procedures | The procedure (day 0) | The number of procedures drilled robotically to the middle ear cavity |
| Blood loss | The procedure (day 0) | Intraoperative blood loss (ml) |
| Postoperative pain | day 0-30 | Pain scale and prescribed pain medication |
| Invasiveness of the intervention | The procedure (day 0) | Size of incision (mm) |
| Adverse events | day 0-30 | Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc |
Countries
Switzerland
Outcome results
None listed