Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
NCT06516211 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 180
Last updated 2026-03-19
Summary
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.
Conditions
- Pregnancy
Interventions
- DEVICE
-
Clara Pregnancy Test
Multi-Level Pregnancy Test
- DEVICE
-
Professional Marketed Pregnancy Test
Early Pregnancy Test
Sponsors & Collaborators
-
Conceptra Biosciences, LLC
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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