Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clara Pregnancy Test, Professional Marketed Pregnancy Test.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Candidate - Predicate Comparison and Lay User-HCP Comparison Study of the Clara(TM) Multi-Level Urine hCG Pregnancy Test
Overview
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.
Interventions
- Device Clara Pregnancy Test
Multi-Level Pregnancy Test - Device Professional Marketed Pregnancy Test
Early Pregnancy Test
Primary outcome measures
- Lay-Professional Comparison [Time frame: 1 day]
Secondary outcome measures (1)
- Predicate Comparison [Time frame: 1 day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- FPA Women's Health — Los Angeles
Identifiers
NCT: NCT06516211 · CCT-101.001