A Candidate - Predicate Comparison and Lay User-HCP Comparison Study of the Clara(TM) Multi-Level Urine hCG Pregnancy Test
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Lay-Professional Comparison
研究概览
简要总结
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing.
Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.
详细描述
Eligible volunteers will be recruited into the study and provide informed consent.
Volunteers will then test their urine sample with the investigational HPT according to the device Instructions For Use, and their results will be recorded. A sample of urine from the same void will be obtained for further testing by the healthcare provider (HCP) study technicians.
The HCP technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires.
True pregnancy status will be determined by laboratory tests and clinical information.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females (persons assigned female at birth and not sterile) willing and able to provide written consent to Study participation
- •Able to read and write in English or Spanish
排除标准
- •Persons employed in a healthcare or laboratory setting and/or with professional experience who conduct point of care urine tests
- •Previous or current enrollment in a Clara™ Study
- •Visually or otherwise impaired to a degree they are not able to readily read and follow instructions, or visualize the faint pink lines.
- •Unwilling or unable to provide at least 12mls of urine specimen and any urine testing they are expected to receive as a part of their non-Study related care.
结局指标
主要结局
Lay-Professional Comparison
时间窗: 1 day
Demonstration of agreement of pregnancy test reading. The agreement between lay participant test results and those of a technician testing the same urine sample.
次要结局
- Predicate Comparison(1 day)