Entia Liberty: Clinical Performance Validation - Capillary Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Entia Ltd
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To obtain/validate the value of the bias of the Entia Liberty device.
研究概览
简要总结
This study is a clinical performance validation study to evaluate the performance of the Entia Liberty device. Patients undergoing routine venepuncture blood tests will be recruited to have an Entia Liberty test (by finger-prick) done on them by a trained healthcare professional. The results from that finger-prick test will be compared against the results from the routine venepuncture blood test (reference method) and subsequently, excess blood from the routine venepuncture test will be run on another Entia Liberty device in the laboratory. All three results (Entia Liberty capillary, Entia Liberty venous and gold standard venous) will be compared against each other to prove Entia Liberty's performance claims.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Age >18 years old at the time of study entry
- •Currently receiving standard of care systemic anti- cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle.
- •Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care
- •Can provide written informed consent
- •Blood samples collected and stored in K2-EDTA vacutainers only
排除标准
- •Known inherited or acquired bleeding disorder
- •History of haematological malignancy
- •Known poorly controlled anti-coagulation
- •Inadequate use and understanding of the English language, requiring a translator
结局指标
主要结局
To obtain/validate the value of the bias of the Entia Liberty device.
时间窗: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain/validate the value of the total error of the Entia Liberty device.
时间窗: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain/validate the value of the linearity of the Entia Liberty device.
时间窗: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
次要结局
未报告次要终点