First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria

• Conditions: Deafness

• Registration Number: NCT04795986
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Status Verified: 2021-09
• Study Start: 2021-09-17
• Last Update Submitted: 2021-09-25
• Last Update Posted: 2021-09-28
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.

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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  • Invalid or withdrawn informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy of cochlear access	at implantation	Percentage of patients with successful cochlear access with the hearo procedure (successful meaning no conventional mastoidectomy and posterior tympanotomy necessary)

Secondary Outcome Measures

Name	Time	Method
electrode array insertion outcomes	at implantation	Percentage of patients with full electrode insertion (all contacts inside the cochlea) as assessed by postoperative DVT Imaging
Safety of cochlear access	at implantation	Number of patients with facial nerve paralysis after cochlear implantation as assessed by the House-Brackmann scale.

Trial Locations

Locations (1)

HNO Klinik am AKH Wien; 🇦🇹 Vienna, Wien, Austria