The Efficacy of a Minimally Invasive Direct Cochlear Access Via the HEARO Procedure
NCT ID: NCT04102215
Last Updated: 2020-10-06
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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UNKNOWN
NA
25 participants
INTERVENTIONAL
2019-09-01
2020-11-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARCI25
Robot assited Cochlear implant surgery.
HEARO
Robotic system for otological procedures
OTOPLAN
Otological surgical planning software
Interventions
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HEARO
Robotic system for otological procedures
OTOPLAN
Otological surgical planning software
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* Distance of the planned trajectory to the facial nerve is \< 0.4mm
* Distance of the planned trajectory to the chorda tympani is \< 0.3mm
* Vulnerability
* Invalid or withdrawn informed consent
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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Central Contacts
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Facility Contacts
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References
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Heuninck E, Van de Heyning P, Van Rompaey V, Mertens G, Topsakal V. Audiological outcomes of robot-assisted cochlear implant surgery. Eur Arch Otorhinolaryngol. 2023 Oct;280(10):4433-4444. doi: 10.1007/s00405-023-07961-7. Epub 2023 Apr 12.
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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000523
Identifier Type: -
Identifier Source: org_study_id
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