Clinical Data Collection On Advanced CT System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Data Collection
研究概览
简要总结
The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.
详细描述
Images from prior standard of care diagnostic CT exams for these subjects will also be collected. Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in Sweden.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25 years of age or older;
- •Able to sign and date the informed consent form; AND
- •Have undergone a clinically indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities where images are available within 90 days of investigational scanning.
排除标准
- •Pregnant or lactating;
- •Previously enrolled in this study;
- •For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
- •For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
- •Need urgent or emergent care;
- •Have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR
- •Are unwilling to have GEHC personnel present for the CT exam.
研究组 & 干预措施
Single Arm
Enrolled subjects will receive a non-diagnostic CT scan on the pre-market, investigational Edge-on Silicon Photon Counting CT device.
干预措施: Investigational Edge-on Silicon Photon Counting CT device (Device)
结局指标
主要结局
Data Collection
时间窗: 12 months
Raw investigational CT scan data along with standard of care raw CT scan data/images
次要结局
- Safety Information(12 months)
- Image Quality(12 months)