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

July 23, 2019 updated by: Prof. Vedat Topsakal
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Minimally invasive robotic cochlear implantation with HEARO
Device: HEARO
Robotic system for otological procedures
Other Names:
  • HEARO procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Image data aquired during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of completed middle ear access
Time Frame: The procedure (day 0)
The procedure (day 0)
Number of completed inner ear access
Time Frame: The procedure (day 0)
The procedure (day 0)
Accuracy of the drilled trajectory
Time Frame: Image data aquired during the procedure
Image data aquired during the procedure
Sensitivity and specificity of facial nerve monitoring
Time Frame: The procedure (day 0)
The procedure (day 0)
Measurement of the insertion angle
Time Frame: Image data aquired during the procedure
Measurement of the insertion depth of the electrode into the Cochlea
Image data aquired during the procedure
Number of tip fold-overs
Time Frame: The procedure (day 0)
The procedure (day 0)
Number of Scala deviations
Time Frame: The procedure (day 0)
The procedure (day 0)
Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection
Time Frame: day 0-30
day 0-30
Time of procedure
Time Frame: The procedure (day 0)
The procedure (day 0)
Volume of tissue removed
Time Frame: Image data aquired during the procedure
Image data aquired during the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Vedat Topsakal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 24, 2018

Primary Completion (ACTUAL)

April 27, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (ACTUAL)

November 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B300201837507

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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