CT 5400 RT System Application Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- the satisfaction of the common functions
研究概览
简要总结
The purpose of this study is to assess the satisfaction of the common functions, the operation convenience, and the whole system stability, and the safety of CT 5400 RT 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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18≤ Age ≤ 75 years old
- •Subjects with Clear consciousness; Subjects can cooperate and act autonomously
- •Subjects agree to participate in this clinical study and sign the subject's informed consent
- •Women subjects of childbearing age should have a negative pregnancy test and should have no plans to become pregnant in the next 6 months
排除标准
- •Subjects who do not have full capacity for civil conduct;
- •Women subjects who are pregnant or in lactating phase;
- •Subjects who have had a CT scan within one year;
- •Subjects with a history of allergies or asthma, severe hepatic and renal insufficiency or hyperthyroidism in which are considered as contraindication for CT contrast-enhanced examination;
- •According to the opinion of the investigator: any situation that may affect the evaluation of the results or expose subjects into health risk;
- •Subjects with mental disorders who cannot cooperate with the examination
结局指标
主要结局
the satisfaction of the common functions
时间窗: 30 days (anticipated)
A three-scale assessment will be used for Image exposure level, couch movement, speaker\& microphone voice quality, image post processing capability, data storage. A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.
the operation convenience assessment
时间窗: 30 days (anticipated)
A three-scale assessment will be used for laser positioning, panel control, user-friendly interface of post-processing software, operation of post-processing software. A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.
the system stability assessment
时间窗: 30 days (anticipated)
A three-scale assessment will be used for workflow, Image display and transmission, system inactivation, unexpected system shutdown, unexpected termination during scanning, fail to expose during scanning A three-scale criteria- Very satisfied, Satisfied, Dissatisfied Assessment criteria: all parameters will be assessed based on the user's feelings. The parameters should all reach "Satisfied", indicating that the general function of the case meet the clinical application requirements.
次要结局
未报告次要终点