NCT04207554已完成不适用
Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 6
- 主要终点
- Overall percent (%) agreement
研究概览
简要总结
The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Healthy adult women of childbearing age.
- •Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.
- •Signed and dated informed consent.
排除标准
- •Adults who are unable to independently give consent for study.
- •Known pregnancy (i.e. - patient appears obviously pregnant).
- •Recent miscarriage or abortion and yet to have 2 complete menstrual cycles before study start.
- •History of ectopic pregnancy, fibroids, congenital uterine anomaly that causes an irregular-shaped uterus.
- •Taken any of the medications of contraceptives containing estrogen in last two weeks.
- •Hemodynamically unstable.
- •Moderately to severely ill-appearing or in moderate to severe pain.
- •Technically not possible to obtain blood or urine from the study subject.
结局指标
主要结局
Overall percent (%) agreement
时间窗: 3 months
The primary endpoint is the overall percent (%) agreement, which is the percentage of total subjects where the test (Preview® hCG Urine/Serum Combo Pregnancy Test) and the reference test (QuickVue+ hCG Combo Test) agree.
次要结局
- Positive and negative percent agreement(3 months)
研究者
研究点 (6)
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