Performance of Centargo - A Novel Piston-based Injection System for High Throughput in Contrast-enhanced Computed Tomography (CE CT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 2
- 主要终点
- Teardown time of CT-system
研究概览
简要总结
This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector.
详细描述
The study compares an investigational injection system (Centargo) for computed tomography (CT) to a currently marketed injection system (Stellant MP) in terms of efficiency, cost, performance and user satisfaction (Part 1). In addition, the reliability of the new injection system Centargo is tested (Part 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Adult subjects referred for contrast-enhanced computer tomography using a power injector
排除标准
- •Pregnant and lactating women
- •Subjects with know hypersensitivity to iodinated contrast media
- •Subjects with unacceptable renal function per local guidelines
研究组 & 干预措施
CT patients_Centargo_1
Adult patients referred for contrast-enhanced computed tomography in study part 1
干预措施: Centargo injector (BPI 1000045) (Device)
CT-patients_Stellant_1
Adult patients referred for contrast-enhanced computed tomography in study part 1
干预措施: Stellant MP injector (Device)
CT-patients_Centargo_2
Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1)
干预措施: Centargo injector (BPI 1000045) (Device)
结局指标
主要结局
Teardown time of CT-system
时间窗: 1 day
Setup time of CT systems
时间窗: 1 day
Change time for bottle/ bag containing contrast medium
时间窗: 1 day
Number of multi-patient sets per day
时间窗: 1 day
Patient setup time for the multi-patient set per day
时间窗: 1 day
次要结局
- Total cost for multi-patients set and disposables per patient and day(1 day)
- Volume of unused saline at teardown time(1 day)
- Volume of contrast agent delivered through injector(1 day)
- Injector-generated pressure(1 day)
- Number of errors requiring a CT-system reboot(1 day)
- Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours(1 day)
- Volume of unused contrast agent at teardown time(1 day)
- Number of automated system alerts(1 day)
- Radiographer satisfaction with contrast-media injector by study-related questionnaire(Up to 4.5 months)
- Flow rate of contrast agent through the injector(1 day)