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

Sensorineural Hearing Loss Clinical Trial

Official title:
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03746613
Study type Interventional
Source University Hospital, Antwerp
Contact
Status Completed
Phase N/A
Start date September 24, 2018
Completion date June 1, 2019
View Details
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