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An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases
Pain palliation of bone metastasis through localized denervation by thermal ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRgHIFU treatment arm | Experimental | Subjects will receive MRgHIFU treatment by using ArcBlate Focused Ultrasound Ablation System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ArcBlate Focused Ultrasound Ablation System | Device | MR-guided High Intensity Focused Ultrasound (MRgHIFU) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unanticipated adverse device effects (UADEs) from Day 0 to 90. | UADEs is defined as any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. | from Day 0 to 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited events from Day 0 to 30 | Major adverse events (Day 0 to 7)、Solicited adverse events (Day 0 to 30) | from Day 0 to 30 |
| Unsolicited adverse events from Day 0 to 90 | Unsolicited adverse events are defined as whose nature or intensity are not consistent with the solicited AE. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng-Xian Yan | Contact | +886-3-5712354 | angelay@episonica.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | New Taipei City | 220 | Taiwan | |||
| Taichung Veterans General Hospital |
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| from Day 0 to 90 |
| Taichung |
| 407 |
| Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Chang Gung Memorial Hospital - Linkou | Taoyuan | 333 | Taiwan |