NCT06769594招募中不适用
Clinical Feasibility and Evaluation of Silicon Photon Counting CT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Data Collection
研究概览
简要总结
The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.
详细描述
Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise to evaluate the product. This data and analysis will help support regulatory submission.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Subjects may be included in this study if they meet the following criteria:
- •Who are 18 year of age or older;
- •Able to sign and date the informed consent form; AND
- •Who have in the past 120 days or will in the future 30 days from the day of consent undergo a clinically indicated imaging exam (MRI, CT, radiograph, nuclear medicine, ultrasound, bone material density, interventional radiology procedure) of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior exam.
排除标准
- •Subjects may be excluded from participating in study if they meet any of the following criteria:
- •Who are pregnant or lactating;
- •Who were 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;
- •Who are in need of urgent or emergent care;
- •Who 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; and,
- •Who are unwilling to have GEHC personnel present for the CT exam.
结局指标
主要结局
Data Collection
时间窗: 12 months
Number of investigational CT scans along with standard of care CT images
次要结局
- Safety Information(12 months)
- Assessment of Image Quality(12 months)
研究者
研究点 (1)
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