NCT06228118已完成不适用
Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Comparison results
研究概览
简要总结
This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.
Lay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Method comparison study exclusion criteria
- •18-55 years of age；
- •Voluntary and sign informed consent form.
- •Lay user study inclusion criteria
- •18-55 years of age；
- •Voluntary and sign informed consent form；
- •Willingness to perform self-test of investigational device；
- •Have the ability to read English.
排除标准
- •Method comparison study exclusion criteria
- •Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
- •Within 8 weeks of childbirth or abortion；
- •The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
- •Lay user study inclusion criteria
- •Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
- •Within 8 weeks of childbirth or abortion；
- •The investigator has reason to believe that it is inappropriate for subjects to participate in the study；
- •Background in a medical or laboratory testing.
结局指标
主要结局
Comparison results
时间窗: 30minute
Compare the test results conducted by professionals using investigational device and the comparator, and the positive percent agreement (PPA=100%), negative percent agreement (NPA=100%) and overall percent agreement (OPA=100%) were calculated.
次要结局
- Evaluate the usability and user comprehension of investigational device(30minute)
研究者
研究点 (1)
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