Status:
NOT_YET_RECRUITING
Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
Lead Sponsor:
Conceptra Biosciences, LLC
Conditions:
Pregnancy
Eligibility:
FEMALE
18+ years
Brief 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 prod...
Detailed Description
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 U...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06516211
Start Date
September 30 2025
End Date
March 31 2026
Last Update
August 26 2025
Active Locations (1)
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1
FPA Women's Health
Los Angeles, California, United States, 90022