Celsius TCS Hyperthermia System Post Market Clinical Follow-Up (PMCF) Trial - Vigilance Registry
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- failures of the device as well as failure of persons using the device during treatment
研究概览
简要总结
Based on the basic data of all patients foreseen for a local hyperthermia in the participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the complication rate (injury to the patients) will be recorded.
详细描述
During this PMCF Trial from each participating center the internal data of all Celsius TCS Hyperthermia devices are collected. The participating centers are obligated to report any device-related failure and Adverse Event (injury to the patient). The center reports together with the device-internal data allows to calculate the failure and the complication rates. It will be analyzed regarding the kind of tumor and the concomitant treatment (radiotherapy and/or chemotherapy). The outcome groups (with/without failure or complication) will be analyzed regarding demographic and treatment parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment performed with the Celsius TCS Hyperthermia System
排除标准
- •not applicable -
结局指标
主要结局
failures of the device as well as failure of persons using the device during treatment
时间窗: one month after treatment
Based on the risk analysis the failures occurring during treatment will be classified and their frequency will be evaluated. This will be done using the investigators' judgment regarding severity of the failures (as minor, moderate, severe).
any injury, harm or medically relevant discomfort occurring for the patients or the staff
时间窗: one month after treatment
Based on the risk analysis the injuries occurring during treatment will be classified and their frequency will be evaluated. This will be done using the investigators' judgment regarding severity of the failures (as minor, moderate, severe).
次要结局
未报告次要终点