Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques (EAR2OS)

Prof. Vedat Topsakal

Status: Completed

Conditions: Sensorineural Hearing Loss

Treatments: Device: HEARO

Study type: Interventional

Funder types: Other

Identifiers

NCT03746613

B300201837507

Details and patient eligibility

About

To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.

Full description

• Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults.
• Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation.
• Validate the system and procedure safety mechanisms.
• Collect required data for validation of safety algorithms and procedure workflow optimisation.
• Validate the HEARO system.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from profound sensorineural deafness requiring a Cochlear implant

Exclusion criteria

• Age under 18 years
• Pregnant women
• Anatomical anomalies of temporal bone
• Chronic otitis media with or without cholesteatoma

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Minimally invasive robotic cochlear implantation with HEARO

Experimental group

Treatment:

Device: HEARO