NCT01909180已完成不适用
Clinical Evaluation for GE CT System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Image Quality
研究概览
简要总结
An external evaluation to obtain clinical data to create sample clinical images.
The data will also be used for product and technology development, marketing materials, and inclusion in publications.
详细描述
The image data were assessed using a Likert scale for image quality sufficient for diagnostic assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who voluntarily signed the Informed Consent Form (ICF).
- •Male subjects 18 years of age or older.
- •Female subjects 18 years of age or older. Females between 18 and 60 years of age must be non-lactating and non-pregnant as confirmed by negative urine pregnancy test., unless they had surgery resulting in sterilization or are post-menopausal according to the medical history.
排除标准
- •• Subjects previously enrolled in this Evaluation.
- •Subjects who are not able or not willing to give written Informed Consent.
- •For IV contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents or a history of multiple allergies or asthma.
- •For IV contrast-enhanced CT exams, per the institution's guidelines on risk stratification and prophylaxis for Contrast Induced Neuropathy, subjects will be pre-screened via medical history review by qualified medical personnel for suspected renal function impairment and high risk subjects will undergo a serum creatinine lab test. Any subject with proven renal insufficiency will be excluded.
- •Known pregnancy and nursing (lactating) females.
- •Any subject with urgent medical condition requiring acute care.
- •Any conditions that, in the opinion of the Investigator, would interfere with the evaluation of the results or constitute a health hazard for the subject.
- •Subjects who do not agree to allow GEHC personnel to be present during the scan.
结局指标
主要结局
Image Quality
时间窗: 24 hours
Image quality assessment on a 5 point Likert Scale: 5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information 1= Non-Diagnostic
次要结局
未报告次要终点
研究者
研究点 (2)
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