Status:
UNKNOWN
The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
Lead Sponsor:
Prof. Vedat Topsakal
Conditions:
Sensorineural Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
Eligibility Criteria
Inclusion
- Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Exclusion
- 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- Invalid or withdrawn informed consent
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 4 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04102215
Start Date
September 1 2019
End Date
November 4 2020
Last Update
October 6 2020
Active Locations (1)
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1
Antwerp University Hospital
Antwerp, Belgium