Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
Completed
Conditions studied: Pregnancy
In brief
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.
Key facts
- Study ID
- NCT04207554
- Run by
- Guangzhou Wondfo Biotech Co., Ltd
- People needed
- 132
- Starts
- 2019-12-05
- Expected to finish
- 2020-12-29
- Last updated by the study team
- 2021-01-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- Minors.
- 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.
Where it is running
- National Insitute of Clinical Research — Garden Grove, California, United States
- National Research Institute-Huntington Park — Huntington Park, California, United States
- Downtown L.A. Research Center, Inc — Los Angeles, California, United States
- National Research Institute-Westlake — Los Angeles, California, United States
- National Research Institute-Panorama City — Panorama City, California, United States
- National Research Institute-Santa Ana — Santa Ana, California, United States
Full record on ClinicalTrials.gov
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