Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
NCT ID: NCT03746613
Last Updated: 2019-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2018-09-24
2019-06-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Minimally invasive robotic cochlear implantation with HEARO
HEARO
Robotic system for otological procedures
Interventions
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HEARO
Robotic system for otological procedures
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant women
* Anatomical anomalies of temporal bone
* Chronic otitis media with or without cholesteatoma
18 Years
ALL
No
Sponsors
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Prof. Vedat Topsakal
OTHER
Responsible Party
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Prof. Vedat Topsakal
Principal Investigator
Locations
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Antwerp University Hospital
Antwerp, , Belgium
Countries
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References
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Topsakal V, Heuninck E, Matulic M, Tekin AM, Mertens G, Van Rompaey V, Galeazzi P, Zoka-Assadi M, van de Heyning P. First Study in Men Evaluating a Surgical Robotic Tool Providing Autonomous Inner Ear Access for Cochlear Implantation. Front Neurol. 2022 Mar 21;13:804507. doi: 10.3389/fneur.2022.804507. eCollection 2022.
Other Identifiers
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B300201837507
Identifier Type: -
Identifier Source: org_study_id
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