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NOT YET RECRUITING
NCT06516211

Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test

Sponsor: Conceptra Biosciences, LLC

View on ClinicalTrials.gov

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.

Official title: A Candidate - Predicate Comparison and Lay User-HCP Comparison Study of the Clara(TM) Multi-Level Urine hCG Pregnancy Test

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2026-06-30

Completion Date

2027-12-31

Last Updated

2026-03-19

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Clara Pregnancy Test

Multi-Level Pregnancy Test

DEVICE

Professional Marketed Pregnancy Test

Early Pregnancy Test

Locations (1)

FPA Women's Health

Los Angeles, California, United States