Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Accuracy of measurement of the INR with the study device
研究概览
简要总结
The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).
详细描述
The investigators will assess the performance of an in vitro diagnostic device for assessing the INR.
The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.
The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.
A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients treated with vitamin K agonist or healthy volunteers
- •For healthy volunteers : Body Mass index between 18 ans 29 kg/m²
- •No acute disease in the previous month
排除标准
- •Pregnant woman
研究组 & 干预措施
Evaluation of the device perfomance
干预措施: Self testing INR device (Device)
结局指标
主要结局
Accuracy of measurement of the INR with the study device
时间窗: Just after the blood taken at day 1
The INR value of each measure with the study device will be compared to the reference INR measured by a central laboratory on a concomitant venous blood sample.
次要结局
- Repeatability of measurement of the INR with the study device(Just after the blood taken at day 1)
- Reproductibility of measurement of the INR with the study device(Just after the blood taken at day 1)