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
|Condition or disease||Intervention/treatment||Phase|
|Sensorineural Hearing Loss||Device: HEARO||Not Applicable|
- 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)|
|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|
|Experimental: Minimally invasive robotic cochlear implantation with HEARO||
Robotic system for otological procedures
Other Name: HEARO procedure
- 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 ]
- Number of completed middle ear access [ Time Frame: The procedure (day 0) ]
- Number of completed inner ear access [ Time Frame: The procedure (day 0) ]
- Accuracy of the drilled trajectory [ Time Frame: Image data aquired during the procedure ]
- Sensitivity and specificity of facial nerve monitoring [ Time Frame: 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
- Number of tip fold-overs [ Time Frame: The procedure (day 0) ]
- Number of Scala deviations [ Time Frame: The procedure (day 0) ]
- Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection [ Time Frame: day 0-30 ]
- Time of procedure [ Time Frame: The procedure (day 0) ]
- Volume of tissue removed [ Time Frame: Image data aquired during the procedure ]
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
|Contact: Vedat Topsokal, Proffirstname.lastname@example.org|
|Contact: Paul Van de Heyning, Prof||003238213245||Paul.VandeHeyning@uza.be|
|Antwerp University Hospital||Recruiting|
|Antwerp, Belgium, 2650|
|Contact: Vedat Topsakal, Prof|