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| ID | Type | Description | Link |
|---|---|---|---|
| PB_2017-0031 | Other Identifier | Ethics commision Bern, Switzerland | |
| 2013-MD-0042 | Other Identifier | Swissmedic (regulatory authority) | |
| CIV-13-12-011779 | Other Identifier | EUDAMED |
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Insufficient enrollment and extended study duration
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| Name | Class |
|---|---|
| University of Bern | OTHER |
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A first in man clinical trial to asses the the use of am image guided robotic system to safely and effectively create a minimally invasive access tunnel to the middle ear cavity to allow access to the round window for cochlear implant electrode insertion.
A first in man feasibility study of an image guided robotic system for performing a key-hole approach to the middle ear cavity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Minimally invasive robotic cochlear implantation with custom device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive robotic cochlear implantation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drilling accuracy | The lateral distance between the center lines of the planned and drilled tunnel positions at the level of the facial nerve measured from medical image data | Image data acquired during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of successfully completed robotic procedures | The number of procedures drilled robotically to the middle ear cavity | The procedure (day 0) |
| The number of successful cochlear implant electrode array insertions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Caversaccio, MD | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital University Hospital Bern | Bern | 3008 | Switzerland |
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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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Number of electrode arrays implanted through the key-hole approach to the middle ear cavity
| The procedure (day 0) |
| Registration accuracy | Fiducial matching error of patient to image registration | The procedure (day 0) |
| Time of the robotic procedure and its subparts | Total time of the robotic procedure from opening to closing (mean and standard deviation) and of the subprocesses | The procedure (day 0) |
| Adverse events | Any clinical complications including facial nerve or chorda tympani damage, infection, negative audiological outcomes etc | day 0-30 |
| Blood loss | Intraoperative blood loss (ml) | The procedure (day 0) |
| Postoperative pain | Pain scale and prescribed pain medication | day 0-30 |
| Invasiveness of the intervention | Size of incision (mm) | The procedure (day 0) |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |