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Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques (EAR2OS)

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ClinicalTrials.gov Identifier: NCT03746613
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Vedat Topsakal, University Hospital, Antwerp

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Device: HEARO Not Applicable

Detailed Description:
  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minimally invasive robotic cochlear implantation with HEARO Device: HEARO
Robotic system for otological procedures
Other Name: HEARO procedure




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746613


Contacts
Contact: Vedat Topsokal, Prof 003238213245 vedat.topsakal@uza.be
Contact: Paul Van de Heyning, Prof 003238213245 Paul.VandeHeyning@uza.be

Locations
Belgium
Antwerp University Hospital Recruiting
Antwerp, Belgium, 2650
Contact: Vedat Topsakal, Prof         
Sponsors and Collaborators
Prof. Vedat Topsakal

Responsible Party: Prof. Vedat Topsakal, Principal Investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03746613     History of Changes
Other Study ID Numbers: B300201837507
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Vedat Topsakal, University Hospital, Antwerp:
robot
Image guidance
Cochlear implantation
navigation
HEARO procedure
sensorineural hearing loss
inner ear access

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms