The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

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Brief Title

The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

Official Title

The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure

Brief Summary

      To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
    



Study Type

Interventional


Primary Outcome

The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy)

Secondary Outcome

 Electrode array insertion depth (Efficacy)

Condition

Sensorineural Hearing Loss

Intervention

HEARO

Study Arms / Comparison Groups

 ARCI25
Description:  Robot assited Cochlear implant surgery.

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

25

Start Date

September 1, 2019

Completion Date

November 1, 2021

Primary Completion Date

September 1, 2021

Eligibility Criteria

        Inclusion Criteria:

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

        Exclusion Criteria:

          -  Age under 18 years

          -  Pregnancy

          -  Distance of the planned trajectory to the facial nerve is < 0.4mm

          -  Distance of the planned trajectory to the chorda tympani is < 0.3mm

          -  Vulnerability

          -  Invalid or withdrawn informed consent
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 003238213245, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04102215

Organization ID

000523


Responsible Party

Sponsor-Investigator

Study Sponsor

Prof. Vedat Topsakal


Study Sponsor

, , 


Verification Date

June 2020