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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive robotic cochlear implantation with HEARO | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEARO | Device | Robotic system for otological procedures |
|
| Measure | Description | 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. | Image data aquired during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of completed middle ear access | The procedure (day 0) | |
| Number of completed inner ear access | The procedure (day 0) | |
| Accuracy of the drilled trajectory |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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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| Image data aquired during the procedure |
| Sensitivity and specificity of facial nerve monitoring | The procedure (day 0) |
| Measurement of the insertion angle | Measurement of the insertion depth of the electrode into the Cochlea | Image data aquired during the procedure |
| Number of tip fold-overs | The procedure (day 0) |
| Number of Scala deviations | The procedure (day 0) |
| Number of complication events on (temporary) facial nerve palsy, pre and post bleeding and infection | day 0-30 |
| Time of procedure | The procedure (day 0) |
| Volume of tissue removed | Image data aquired during the procedure |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |