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Completed

NCT Number: NCT04610450

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

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.

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Key information

Conditions

Sensorineural Hearing Loss 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

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

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
  • 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

Treatment and study plan

HEARO

Device

Robotic system for otological procedures

OTOPLAN

Device

Otological surgical planning software

Primary outcomes

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

    Time frame: day 0

    The primary outcome measure of this study is to explore the relative ratio of the successful electrode array insertions into the cochlea through the drilled direct cochlear access with the HEARO procedure to the total HEARO procedures. Aborted or converted procedures count as procedure in which insertion through the direct cochlea access was not possible. The results will be expressed in relative numbers and in percentage.

Secondary outcomes

  1. Electrode array insertion outcome

    Time frame: day 0

    The angular insertion depth (in degrees) will be evaluated.

  2. Electrode array insertion outcome

    Time frame: day 0

    The number of inserted electrode contacts will be evaluated.

  3. Electrode array insertion outcome

    Time frame: day 0

    The surgical outcome (categories: nominal, tip-fold over or scalar deviation) will be evaluated.

  4. Insertion depth prediction accuracy

    Time frame: day 0

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

  5. Absolute angular accuracy of the drilled tunnel access

    Time frame: day 0

    The absolute in-plane and out-plane accuracy of the drilled tunnel is measured as the angular deviation between the planned trajectory in-plane and out-plane angles and the actual drilled angles from the intra-op image.

  6. Absolute lateral accuracy of the drilled tunnel at the facial recess

    Time frame: day 0

    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

    Time frame: day 0

    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

    Time frame: day 0

    The ratio of the visibility of round window membrane surface 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: day 0

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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2020
Registry last updated
Nov 25, 2022

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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