Bone Metastases
Conditions
Brief summary
An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases
Detailed description
Pain palliation of bone metastasis through localized denervation by thermal ablation.
Interventions
MR-guided High Intensity Focused Ultrasound (MRgHIFU)
Sponsors
EpiSonica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, who randomized into Sham control group and withdrew from CTP-BM-22-01 Study (i.e. main study) due to lack of efficacy. 2. Completed 14-day evaluation in main study. 3. Will provide completed and signed written informed consents.
Exclusion criteria
1. Pregnant women. 2. Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e. main study) after re-evaluation. 3. Determined by the investigator to be not suitable for the conduct of the study for any other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unanticipated adverse device effects (UADEs) from Day 0 to 90. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Solicited events from Day 0 to 30 | from Day 0 to 30 | Major adverse events (Day 0 to 7)、Solicited adverse events (Day 0 to 30) |
| Unsolicited adverse events from Day 0 to 90 | from Day 0 to 90 | Unsolicited adverse events are defined as whose nature or intensity are not consistent with the solicited AE. |
Countries
Taiwan
Contacts
Primary ContactFeng-Xian Yan
Outcome results
None listed