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Completed

NCT Number: NCT04777565

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

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

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Key information

Conditions

Sensorineural Hearing Loss, Bilateral Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic surgery

Other

Cochlear implant surgery with HEARO procedure

Primary outcomes

  1. Electrode array insertion

    Time frame: During surgery

    • Relative ratio of successful electrode array insertions through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures (i.e. proportion of successful insertions with the procedure out of the total number of patients included in the study).

Secondary outcomes

  1. Electrode array insertion outcome (efficacy)

    Time frame: During surgery

    • The angular insertion depth will be evaluated.

  2. Electrode array insertion outcome (efficacy)

    Time frame: During surgery

    • The number of contacts inserted will be evaluated.

  3. Electrode array insertion outcome (efficacy)

    Time frame: During surgery

    • The tip-fold over will be evaluated.

  4. Electrode array insertion outcome (efficacy)

    Time frame: During surgery

    • The scalar deviation will be evaluated.

  5. Insertion depth prediction accuracy (efficacy)

    Time frame: During surgery

    • The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth.

  6. Absolute angular accuracy of the drilled tunnel access (safety)

    Time frame: During surgery

    • The absolute lateral accuracy of the drilled tunnel to the facial nerve and chorda tympani is measured as the difference between the planned trajectory and the actual drilled trajectory distance.

  7. Absolute lateral accuracy of the drilled tunnel at the target (safety)

    Time frame: During surgery

    • The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned target trajectory position and actual target of the drilled trajectory position.

  8. Ratio of the round window membrane preservation during the inner ear access (safety)

    Time frame: During surgery

    • The ratio of the preserved round window (RW) membrane at the robotic inner ear access by visual inspection. This will be assessed as subjective evaluation by the surgeon.

  9. Timing of the HEARO procedure

    Time frame: During surgery

    • The timing of the different steps of the HEARO procedure will be recorded.

  10. Adverse events (safety)

    Time frame: During surgery

    • Adverse events will be recorded

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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