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

Conceptra Biosciences

Status

Not yet enrolling

Conditions

Pregnancy

Treatments

Device: Professional Marketed Pregnancy Test

Device: Clara Pregnancy Test

Study type

Observational

Funder types

Industry

Identifiers

NCT06516211

CCT-101.001

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.