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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Conceptra Biosciences, LLC
Study ID
NCT06516211
Status
Not Yet Recruiting

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Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Clara Pregnancy Test — DEVICE
    Multi-Level Pregnancy Test
  • Professional Marketed Pregnancy Test — DEVICE
    Early Pregnancy Test

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Lay User
  • Arm: HCP Predicate Device

Primary Outcome Measure

Lay-Professional Comparison [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
FPA Women's HealthLos AngelesCalifornia90022
Regulatory Conceptra
[email protected]
855-692-5272

Find similar trials in Los Angeles, CA

By research site
FPA Women's Health· Los Angeles, CA

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