Entia Liberty: Usability Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Entia Ltd
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.
研究概览
简要总结
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.
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
- •Can provide written informed consent
- •Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle
- •Sufficient hearing to be able to participate in a video training session
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
- •Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
- •Previously taken part in the 'PERTH-2' study involving a prototype device
结局指标
主要结局
Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.
时间窗: 3 months
At least 24 of the participants are able to complete the Entia Liberty test.
Number of participants with new severe usability problems identified.
时间窗: 3 months
Identification of the number of participants that were deviating away from the instructions for use, resulting in increased risk to the results or themselves
Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
时间窗: 3 months
Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
次要结局
未报告次要终点