Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
NCT ID: NCT06516211
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
180 participants
OBSERVATIONAL
2025-09-30
2026-03-31
Brief Summary
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Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Lay User
Clara Pregnancy Test
Multi-Level Pregnancy Test
HCP Predicate Device
Clara Pregnancy Test
Multi-Level Pregnancy Test
Professional Marketed Pregnancy Test
Early Pregnancy Test
Interventions
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Clara Pregnancy Test
Multi-Level Pregnancy Test
Professional Marketed Pregnancy Test
Early Pregnancy Test
Eligibility Criteria
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Inclusion Criteria
* Able to read and write in English or Spanish
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Conceptra Biosciences, LLC
INDUSTRY
Responsible Party
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Locations
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FPA Women's Health
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCT-101.001
Identifier Type: -
Identifier Source: org_study_id
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