NCT04594577已完成不适用
The Clinical Validation of Fluispotter®, a Novel Automated Body-worn System for Serial Sampling of Venous Dried Blood Spots
Fluisense ApS2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年1月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Number of samplings
研究概览
简要总结
This is a prospective, single-centre, non-comparative, non-randomized, open label, clinical investigation of the clinical performance and safety of Fluispotter. The main aim is to validate the clinical performance and safety of the body-worn Fluispotter system used for automated extraction, collection and storage of 20 dried venous dried blood spot samples of 10 µl over the course of 20 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male or female
- •Able to understand verbal and written instructions in Danish
- •Able and willing to sign and date the informed written consent form and letter of authority
排除标准
- •Currently participating in a clinical trial evaluating drugs or medical devices
- •Known history of coagulation disorders
- •Currently taking regular medication (contraceptives, hormonal replacement therapy and antihistamines exempted)
- •Regular smoking or use of nicotine products
- •Pregnancy
- •Haematocrit < 38% (male); < 33% (female)
- •Haematocrit > 52% (male); > 48% (female)
- •C-reactive protein (CRP) > 10 mg/dL
- •Body Mass Index (BMI) > 30
- •Known allergies or hypersensitivity to flushing solution constituents
- •Other factors which in the opinion of the investigator would interfere with the ability to provide informed consent, comply with study procedures/instructions, or possibly confound the interpretation of the study results or put the subject at undue risk
结局指标
主要结局
Number of samplings
时间窗: 20 hours
Number of successful samplings over a 20-hour period
次要结局
- Procedure(Approximately 60 minutes and 24 hours)
- Usability: User experience based on questionnaire(24 hours)
- Technical performance(20 hours)
- Usability: Subject experience based on questionnaire(24 hours and 8 ± 2 days)
- Clinical safety, safety reporting(8 ± 2 days)
- Clinical safety, systemic effects(24 hours)
研究者
研究点 (2)
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