NCT06516211

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Conceptra Biosciences, LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 Use, and their results will be recorded. A sample of urine from the same void will be obtained for further testing by the healthcare provider (HCP) study technicians. The HCP technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires. True pregnancy status will be determined by laboratory tests and clinical information.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DEVICE	Clara Pregnancy Test	Multi-Level Pregnancy Test
DEVICE	Professional Marketed Pregnancy Test	Early Pregnancy Test

Timeline

• Start date: 2026-06-30
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2024-07-23
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study