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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04795986
Other study ID # HEARO-AT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 17, 2021
Est. completion date December 2023

Study information

Verified date September 2021
Source Medical University of Vienna
Contact Kliniksekretariat HNO Klinik
Phone +43 1 40400 33760
Email klinsek@push-email.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant. Exclusion Criteria: - 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to the facial nerve and 0.3mm to the chorda tympani - Vulnerable or mentally retarded candidates - Invalid or withdrawn informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
HEARO Procedure
robotic access to the middle and inner ear in cochlear implantation

Locations

Country Name City State
Austria HNO Klinik am AKH Wien Vienna Wien

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Vienna MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary efficacy of cochlear access Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary) at implantation
Secondary electrode array insertion outcomes Percentage of patients with full electrode insertion (all contacts inside the cochlea) as assessed by postoperative DVT Imaging at implantation
Secondary Safety of cochlear access Number of patients with facial nerve paralysis after cochlear implantation as assessed by the House-Brackmann scale. at implantation
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