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To study the efficacy of a minimally invasive direct cochlear access via the HEARO procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARCI25 | Experimental | Robot assited Cochlear implant surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEARO | Device | Robotic system for otological procedures |
|
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| Measure | Description | Time Frame |
|---|---|---|
| The relative ratio of the electrode array insertion into the cochlea through the drilled direct cochlea access with HEARO procedure. (Efficacy) | The ratio of the number of the procedures in which it was possible to insert the electrode inside the cochlea through the direct cochlear access compared to the number of procedures in which the insertion through the direct cochlea access was not possible will be calculated. Aborted or converted procedures count as procedure in which insertion through the direct cochlea access was not possible. The results will be expressed in relative numbers (n of 25) and in percentage (%). | Image data aquired during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Electrode array insertion depth (Efficacy) | The electrode insertion depth will be measured in the post-operative image. (Degrees °) | The procedure (day 0) |
| Number of correctlly inserted electrode contact (Efficacy) |
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Inclusion Criteria:
Adult cochlear implant candidates with suitable anatomy opting for a MED-EL cochlear implant.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vedat Topsokal, Prof | Contact | 003238213245 | vedat.topsakal@uza.be | |
| Paul Van de Heyning, Prof | Contact | 003238213245 | Paul.VandeHeyning@uza.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Recruiting | Antwerp | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37043021 | Derived | 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. | |
| 35386404 | Derived | 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. |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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SIngle arm study
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| OTOPLAN | Device | Otological surgical planning software |
|
The number of inserted electrode contacts into the inner ear will be counted in the post-operative image. (Number n)
| The procedure (day 0) |
| Insertion depth prediction accuracy (Efficacy) | The insertion depth prediction accuracy as the difference between the estimated insertion depth of the electrode at the planning and the actual insertion depth. (Degrees °) | The procedure (day 0) |
| Absolute angular accuracy of the drilled tunnel access | The absolute in-plane and out-plane accuracy of the drilled tunnel is measured as the angular deviation between the planned and the actual angles. | The procedure (day 0) |
| Absolute lateral drilling accuracy of the drilled tunnel at the level of facial recess (Safety) | The absolute lateral accuracy of the drilled tunnel to the facial nerve and chorda tympani is measured as the difference between the planned and the actual distance. (mm) | The procedure (day 0) |
| Absolute lateral drilling accuracy of the drilled tunnel at the target (Safety) | The absolute lateral accuracy of the drilled tunnel is measured as the distance between the planned and actual target position. (mm) | The procedure (day 0) |
| Evaluation of the automatic landmark detection (Performance) | The relative ratio of the automatically identified landmarks by OTOPLAN that were not manually adjusted by the surgeon. The intended landmarks are:
| The procedure (day 0) |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |