NCT01375725已完成不适用
Mobius PT-INR Accuracy Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device
研究概览
简要总结
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Are currently taking coumadin (warfarin)
- •Are aged 18 years or older
- •Able and willing to provide informed consent
- •Can understand (read and write) English
- •Required to provide a capillary sample as part of their routine medical check
排除标准
- •Previously participated in this study
结局指标
主要结局
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device
时间窗: Five days to collect data and up to two weeks to generate correlation graph
To determine the correlation of PT/INR values between an experimental and commercial device
次要结局
未报告次要终点
研究者
研究点 (1)
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