ABL90 FLEX PLUS Method Comparison Study for ctBil and FHbF in Neonatal Capillary Whole Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 3
- 主要终点
- Primary Endpoints
研究概览
简要总结
The study is intended to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal capillary whole blood for ctBil and FHbF in a POC setting
详细描述
The objective is to perform a method comparison study to quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for ctBil and FHbF in heparinized capillary whole blood samples in capillary measuring mode (C65).
This study will together with a method comparison study performed with surrogate capillary samples contribute to the overall validation of the performance of ABL90 FLEX for capillary whole blood with regards to the parameters ctBil and FHbF measured using the capillary mode.
This study is anticipated to run for approximately 6-12 months from site initiation visit till close-out visit depending on patient enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent collected from legal representative able to understand information given and willing and able to voluntary give their consent to participate in this study.
- •The age of the subject must be ≤28 days.
- •Subject evaluated as suitable according to the protocol to enrol in the study by principal investigator or designee
排除标准
- •Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
- •Subject, who has an invalid written informed consent or has withdrawn consent.
- •Subject who has already provided successful results from capillary samples, to cover both parameters.
- •Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.
研究组 & 干预措施
Investigational Device
The Investigational Device in this clinical study is the ABL90 FLEX PLUS running SW3.5 MR2 manufactured by Radiometer Medical ApS. The analyzer provides results for 17 parameters in 35 seconds using 65 μL heparinized whole blood. However, in this investigation only the data concerning the parameters ctBil and FHbF will be evaluated.
干预措施: Method Comparison (Device)
Predicate device
The predicate device for this study is the unmodified device ABL90 FLEX PLUS (k160153) running software SW 3.1 MR7 including sensor casettes and solution packs versions corresponding to 2016.
ABL90 FLEX PLUS SW 3.1 MR7, has been selected as the predicate device because it has the appropriate 510(k) clearance, and the intended use matches the ABL90 FLEX PLUS SW. SW3.5 MR2 device.
干预措施: Method Comparison (Device)
结局指标
主要结局
Primary Endpoints
时间窗: 12 months
Bias between device under investigation and comparative device at medical decision level across sites; (unit is mg/dL)
次要结局
- Secondary Endpoints(12 months)