Spectral CT Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Excellent and good rate of clinical imaging (score≥3）
研究概览
简要总结
The purpose of this study was to evaluate the expected effectiveness, ease of operation, stability, and safety of Spectral CT
详细描述
Under the premise of protecting subjects and ensuring the scientific nature of this study, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.
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
- •Recruit volunteers (ages 18 to 75);
- •Negative pregnancy tests in women of childbearing age;
- •Participants who agree to participate in this clinical trial and sign the informed consent;
- •Enhanced scans require laboratory tests to confirm normal renal function.
排除标准
- •Persons who do not have full capacity for civil conduct;
- •Lactating women;
- •People who are not suitable for enhanced scanning with iodine contrast agent;
- •Patients whom the investigator considers inappropriate to participate in this clinical trial.
结局指标
主要结局
Excellent and good rate of clinical imaging (score≥3）
时间窗: through study completion, an average of 1 year
Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory
次要结局
- Common functions assessment(through study completion, an average of 1 year)
- Convenience evaluation assessment(through study completion, an average of 1 year)
- Machine function and stability assessment(through study completion, an average of 1 year)
- Adverse events and serious adverse events(through study completion, an average of 1 year)