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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
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This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention.
This is a prospective, single-arm, single-center study to evaluate the safety and effectiveness of the Remedy Robot for patients with a clinical indication for Neurointervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Group undergoing intervention with the Remedy Robot. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remedy Robot | Device | A trained Neurointerventionalist will operate the Remedy Robot from a computer-based user interface in a room adjacent to the patient. An entire cerebral angiogram or cerebral embolization will be performed, excluding insertion and removal of the femoral sheath. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural safety | Incidence of intra- and peri-procedural events, including all cause mortality, stroke, arterial dissection, arterial perforation | Measured from the start of the procedure through 24 hours or discharge |
| Procedural Technical Success | Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual control | Measured from the start of the procedure through to the completion of the procedure |
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Inclusion criteria
Exclusion criteria:
People with any of the following medical history:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Bell, MD | Contact | 650-441-5019 | david@remedyrobotics.com |
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| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| D002318 | Cardiovascular Diseases |