Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure

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Brief Title

Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure

Official Title

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

Brief Summary

      The objectives of this study are to explore the efficacy and safety of a robotic procedure
      for a minimally invasive cochlear implantation.
    

Detailed Description

      The cochlear implant (CI) is a neural prothesis and has been the gold standard treatment for
      severe to profound sensorineural hearing loss over several decades. The surgical procedure
      for cochlear implantation surgery 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 initially 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 large portions of the mastoid bone through a wide 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 efficacy of the HEARO robotic cochlear implantation
      surgery.

      Primary Objective

      The primary objective of this study is to:

      • explore the efficacy of a minimally invasive direct cochlear access via the HEARO
      procedure.

      Secondary Objectives

      The secondary objectives of this study are to:

        -  explore the safety of a minimally invasive direct cochlear access via the HEARO
           procedure.

        -  exploratively evaluate the electrode array insertion outcomes through the direct tunnel
           access.
    


Study Type

Interventional


Primary Outcome

Electrode array insertion

Secondary Outcome

 Electrode array insertion outcome (efficacy)

Condition

Sensorineural Hearing Loss, Bilateral

Intervention

Robotic surgery

Study Arms / Comparison Groups

 CI surgery
Description:  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

Other

Estimated Enrollment

10

Start Date

September 15, 2021

Completion Date

March 15, 2023

Primary Completion Date

September 15, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects scheduled for CI surgery according to clinical routine

          -  Subjects who will receive a cochlear implant of the MED-EL portfolio

          -  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

          -  Individuals who have known allergy to components of the cochlear implant
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Frédéric Venail, Pr, (+33)603592974, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04777565

Organization ID

MED-EL_HEARO_french_study


Responsible Party

Sponsor

Study Sponsor

MED-EL Elektromedizinische Geräte GesmbH


Study Sponsor

Frédéric Venail, Pr, Principal Investigator, University Hospital, Montpellier


Verification Date

March 2021