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OpenTrials
Completed

NCT Number: NCT03746613

Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques

To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.

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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

Antwerp University Hospital

Antwerp, 2650, Belgium

About this study

  • Demonstrate the feasibility and efficacy of performing a middle and inner ear access for cochlear implantation procedures in adults.
  • Validate the procedure workflow including imaging, planning, safety assessment, image to patient registration, robotic drilling, electrode insertion and device implantation.
  • Validate the system and procedure safety mechanisms.
  • Collect required data for validation of safety algorithms and procedure workflow optimisation.
  • Validate the HEARO system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients suffering from profound sensorineural deafness requiring a Cochlear implant

Exclusion criteria

  • Age under 18 years
  • Pregnant women
  • Anatomical anomalies of temporal bone
  • Chronic otitis media with or without cholesteatoma

Treatment and study plan

HEARO

Device

Robotic system for otological procedures

Other names: HEARO procedure

Primary outcomes

  1. The relative ratio of successfully completed procedures where a direct access tunnel was drilled to the cochlea with the HEARO® system and the electrode was conventionally inserted through the tunnel.

    Time frame: Image data aquired during the procedure

Secondary outcomes

  1. Number of completed middle ear access

    Time frame: The procedure (day 0)

  2. Number of completed inner ear access

    Time frame: The procedure (day 0)

  3. Accuracy of the drilled trajectory

    Time frame: Image data aquired during the procedure

  4. Sensitivity and specificity of facial nerve monitoring

    Time frame: The procedure (day 0)

  5. Measurement of the insertion angle

    Time frame: Image data aquired during the procedure

    Measurement of the insertion depth of the electrode into the Cochlea

  6. Number of tip fold-overs

    Time frame: The procedure (day 0)

  7. Number of Scala deviations

    Time frame: The procedure (day 0)

  8. Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection

    Time frame: day 0-30

  9. Time of procedure

    Time frame: The procedure (day 0)

  10. Volume of tissue removed

    Time frame: Image data aquired during the procedure

Sponsors and collaborators

Lead sponsor

Prof. Vedat Topsakal

Other

Registry information

Acronym: EAR2OS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2018
Registry last updated
Jul 24, 2019

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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