NCT03738670终止不适用
Pain Evaluation After Treatment of Extra-spinal Bone Metastases With OsteoCOOL Radiofrequency (RF) Ablation System
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Percentage of responding patients reporting an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire
研究概览
简要总结
To evaluate the worst pain of cancer patients with painful extra-spinal bone metastases 1 month after bipolar radiofrequency ablation (RFA) performed with the Osteocool system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •1) Multi-metastatic cancer patients with at least one painful lytic bone metastasis
- •2) Target lesion should correspond to a specific radiologic finding
- •3) At least a moderate pain produce by target lesion (4 on a scale of 0 to 10 over the prior 24 hours with or without pain killers intake) assessed during selection evaluation
- •4) Patients 18 years old
- •5) Able to give written consent
- •6) Life expectancy 1 months
- •7) Patient affiliated to the National Health Insurance system
排除标准
- •Radiation therapy on the target tumor terminated < 3 weeks before treatment
- •Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
- •Any contra-indication for the procedure as stated by the radiologist related to patient's condition (e.g. cardiac pacemakers) making the procedure at unacceptable risk
- •Impaired haemostasis
- •Concurrent participation in other experimental studies that could affect endpoints of this study
- •Contraindication to any form of sedation/anaesthesia
- •Signs of local/systemic infection identified before procedure, in accordance with standard care
- •Sclerotic metastases
- •Adults under guardianship
- •Patients under judicial protection
- •Pregnant or breastfeeding woman
结局指标
主要结局
Percentage of responding patients reporting an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire
时间窗: 1 month
次要结局
- Comparison of the mean scores of the items 3, 5, 9B and 8 of the BPI questionnaire between the baseline and 6-month follow-up(6 months)
- Safety will be assessed according to SIR(11) / CTCAE classification(6 months)
- Mean scores variation of the morphine milligram equivalents (MME) (based on patient consumption diary) between the baseline and 6-month follow-up.(6 months)
- Percentage of responding patients defined by an improvement of at least 3 points on item 3 "the worst pain in the last 24 hours" of Brief Pain Inventory (BPI) questionnaire at 3 and 6 month follow-up.(6 months)
研究者
研究点 (2)
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