The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

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Brief Title

The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

Official Title

The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation

Brief Summary

      The cochlear implant is a neural prosthesis and has been the gold standard treatment for
      severe to profound sensorineural hearing loss over several decades. The surgical procedure
      for cochlear implantation aims to atraumatically insert the electrode array of the cochlear
      implant into the cochlea. However, due to the location of the cochlea inside the skull, the
      surgeon is required to create an access from the surface of the temporal bone to the cochlea
      (inner ear). In conventional methods, this access is acquired by removal of portions of the
      mastoid bone through a mastoidectomy and posterior tympanotomy. The outcome and success of
      the conventional procedure varies due to mainly two factors: surgeon skill and subject
      anatomical variation. To overcome these variables toward a more consistent and less invasive
      cochlear implantation surgery, the development of robotic and image guided cochlear
      implantation has taken place. This study primarily aims to explore the performance of robotic
      cochlear implantation surgery.
    



Study Type

Interventional


Primary Outcome

Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures.

Secondary Outcome

 Electrode array insertion outcome

Condition

Sensorineural Hearing Loss

Intervention

HEARO

Study Arms / Comparison Groups

 RCI-BE-10
Description:  Robot assisted 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

10

Start Date

April 26, 2021

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects scheduled for CI surgery according to clinical routine

          -  Subjects who will receive a cochlear implant

          -  Signed and dated informed consent form

        Exclusion Criteria:

          -  Lack of compliance with any inclusion criteria

          -  Age under 18 years

          -  Pregnancy

          -  Distance of the planned trajectory to the facial nerve is < 0.4 mm as per screening CT
             scan

          -  Distance of the planned trajectory to the chorda tympani is < 0.3 mm as per screening
             CT scan

          -  A safe inner ear access cannot be planned for preservation of RW membrane and cochlear
             structures

          -  Individuals where image guidance or robotic procedures are not indicated
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Marco Caversaccio, Prof. Dr., , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT04610450

Organization ID

RCI-NEXT


Responsible Party

Sponsor

Study Sponsor

University Hospital Inselspital, Berne


Study Sponsor

Marco Caversaccio, Prof. Dr., Principal Investigator, University Hospital Bern (Inselspital)


Verification Date

April 2021