NCT05537779尚未招募不适用
Safety and Performance of Optivantage Multi-use Solution When Injecting Contrast Media to Subjects Requiring Contrast Enhanced CT Examination
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Guerbet
- 入组人数
- 100
- 主要终点
- Safety of Optivantage
研究概览
简要总结
The study is a prospective, single-arm observational multicenter clinical investigation.
The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.
详细描述
Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System.
100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.
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
- 2 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject referred for a contrast-enhanced CT examination using a power injector
- •Subject or legal representative for children, having provided written informed consent
排除标准
- •Subject weighting less than 10 kg
- •Pregnant or breastfeading woman subject
- •Subject with known allergy or hypersensitivity to contrast media
- •Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics
- •Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection
- •Subject unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study
结局指标
主要结局
Safety of Optivantage
时间窗: Per procedure
Rate of extravasation
Performance of Optivantage
时间窗: Per procedure
Success of injection
次要结局
- Device deficiencies(Per procedure)
- Safety of Optivantage(Per procedure)
研究者
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