Status:
UNKNOWN
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
MED-EL Elektromedizinische Geräte GesmbH
Conditions:
Deafness
Eligibility:
All Genders
18-99 years
Brief Summary
To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.
Detailed Description
The HEARO procedure involves a robot which drills the access to the cochlear in cochlear implantation. The study is an observational study of the first implementation in clinical routine in Austria.
Eligibility Criteria
Inclusion
- Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Exclusion
- Age under 18 years
- Pregnant women
- Facial recess size does not allow a minimum distance of 0.4mm from the planned trajectory to the facial nerve and 0.3mm to the chorda tympani
- Vulnerable or mentally retarded candidates
- Invalid or withdrawn informed consent
Key Trial Info
Start Date :
September 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04795986
Start Date
September 17 2021
End Date
December 1 2023
Last Update
September 28 2021
Active Locations (1)
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1
HNO Klinik am AKH Wien
Vienna, Vienna, Austria, 1090