Project-0027 Lay User Usage Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 943
- 试验地点
- 1
- 主要终点
- Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status
研究概览
简要总结
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre 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.
Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.
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 record their result onto the results sheet. A sample of urine from the same void will be obtained for further testing by the study technicians.
The technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a Clearblue Digital 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.
At the end of the study visit, all volunteers will be provided with materials to allow follow-up for the determination of pregnancy status.
The majority of volunteers will be requested to provide one additional urine sample, collected 2 days after the study visit. If early pregnancy is suspected the volunteer will be requested to provide an additional 7 daily urine samples following the study visit. All volunteers will be required to provide details of pregnancy status (documented menses or pregnancy confirmation by health care professional) after the study visit.
True pregnancy status will be determined by laboratory tests and clinical information. The study will continue until a minimum of 300 pregnant and 300 not pregnant volunteers have completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Aged 18 or over
- •Willing to conduct a personal pregnancy test and reveal their pregnancy status
- •Willing to give informed consent
排除标准
- •Currently or previously employed by SPD Development Company Ltd. (SPD), Alere, Unipath, Procter and Gamble (P&G), or affiliates.
- •Has an immediate relative* currently or previously employed by SPD, Alere, Unipath or P&G or affiliates
- •Previously used the investigational HPT within the last six months
- •Healthcare professionals (HCP's) with professional experience either using lateral flow based devices or conducting near patient testing
- •Confirmed to be pregnant by a healthcare professional and beyond the first trimester
- •Taken a hormonal preparation containing human chorionic gonadotropin (hCG) in the last month, e.g. Pregnyl®
研究组 & 干预措施
Pregnancy test
Clearblue investigational Pregnancy test
Clearblue Marketed pregnancy test
Professional pregnancy test
干预措施: Clearblue Investigational Pregnancy test (Other)
Pregnancy test
Clearblue investigational Pregnancy test
Clearblue Marketed pregnancy test
Professional pregnancy test
干预措施: Professional pregnancy test (Other)
Pregnancy test
Clearblue investigational Pregnancy test
Clearblue Marketed pregnancy test
Professional pregnancy test
干预措施: Clearblue Marketed Pregnancy test (Other)
结局指标
主要结局
Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status
时间窗: 3 months
The accuracy of the investigational HPT in volunteer hands compared to pregnancy status
次要结局
- Number of participants recording a false positive or false negative pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status.(3 months)
- Number of participants recording the same pregnancy test result as a laboratory technician when testing their own urine sample with the investigational HPT.(3 months)
- Calculation of the level of certainty a user can have if the device gives a pregnant (positive predictive value (PPV)) or not pregnant result (Negative predictive value(NPV)).(3 months)
- Number of participants correctly answering questions about the product when referencing the instructions for use (IFU) leaflet.(3 months)
- Participants opinion on using the product.(3 months)