NCT06487026尚未招募不适用
An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases
EpiSonica8 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Unanticipated adverse device effects (UADEs) from Day 0 to 90.
研究概览
简要总结
An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases
详细描述
Pain palliation of bone metastasis through localized denervation by thermal ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Completed 14-day evaluation in main study.
- •Will provide completed and signed written informed consents.
排除标准
- •Pregnant women.
- •Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e. main study) after re-evaluation.
- •Determined by the investigator to be not suitable for the conduct of the study for any other reasons.
结局指标
主要结局
Unanticipated adverse device effects (UADEs) from Day 0 to 90.
时间窗: 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.
次要结局
- Solicited events from Day 0 to 30(from Day 0 to 30)
- Unsolicited adverse events from Day 0 to 90(from Day 0 to 90)
研究者
研究点 (8)
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