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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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 Type

Interventional


Primary Outcome

The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.

Secondary Outcome

 Number of completed middle ear access

Condition

Sensorineural Hearing Loss

Intervention

HEARO

Study Arms / Comparison Groups

 Minimally invasive robotic cochlear implantation with HEARO
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

3

Start Date

September 24, 2018

Completion Date

June 1, 2019

Primary Completion Date

April 27, 2019

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT03746613

Organization ID

B300201837507


Responsible Party

Sponsor-Investigator

Study Sponsor

Prof. Vedat Topsakal


Study Sponsor

, , 


Verification Date

July 2019