Finished
The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
NCT04610450 · Insel Gruppe AG, University Hospital Bern · Updated 25 Nov 2022
- What is being tested
- HEARO; OTOPLAN
- For
- Sensorineural Hearing Loss
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 3 people. The full rules are on the registry page.
- Where
- Switzerland
- When
- Starts or started 26 April 2021, ends 23 Nov 2022. Registered 30 Oct 2020.
- Results
- None posted yet.
In the researchers' words
The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades. The surgical procedure for cochlear implantation aims to atraumatically insert the electrode array of the cochlear implant into the cochlea. However, due to the location of the cochlea inside the skull, the surgeon is required to create an access from the surface of the temporal bone to the cochlea (inner ear). In conventional methods, this access is acquired by removal of portions of the mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of the conventional procedure varies due to mainly two factors: surgeon skill and subject anatomical variation. To overcome these variables toward a more consistent and less invasive cochlear implantation surgery, the development of robotic and image guided cochlear implantation has taken place. This study primarily aims to explore the performance of robotic cochlear implantation surgery.
Sites
- Inselspital, Bern University HospitalBern, Switzerland
