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

Not yet recruiting

• Conditions: Pregnancy
• Interventions: Device: Clara Pregnancy Test; Device: Professional Marketed Pregnancy Test

• Registration Number: NCT06516211
• Lead Sponsor: Conceptra Biosciences, LLC

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 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.

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-23
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Study Start: 2025-04-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 180

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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCP Predicate Device	Clara Pregnancy Test	-
Lay User	Clara Pregnancy Test	-
HCP Predicate Device	Professional Marketed Pregnancy Test	-

Primary Outcome Measures

Name	Time	Method
Lay-Professional Comparison	1 day	Demonstration of agreement of pregnancy test reading. The agreement between lay participant test results and those of a technician testing the same urine sample.

Secondary Outcome Measures

Name	Time	Method
Predicate Comparison	1 day	Demonstration of agreement of pregnancy test reading. The agreement between the predicate device and investigational device test results performed by a technician testing the same urine sample.

Trial Locations

Locations (1)

FPA Women's Health; 🇺🇸 Los Angeles, California, United States