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

March 17, 2026 updated by: Conceptra Biosciences, LLC

A Candidate - Predicate Comparison and Lay User-HCP Comparison Study of the Clara(TM) Multi-Level Urine hCG Pregnancy Test

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90022
        • FPA Women's Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Females over the age of 18, who are capable of becoming pregnant.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lay User
Device: Clara Pregnancy Test
Multi-Level Pregnancy Test
HCP Predicate Device
Device: Clara Pregnancy Test
Multi-Level Pregnancy Test
Device: Professional Marketed Pregnancy Test
Early Pregnancy Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lay-Professional Comparison
Time Frame: 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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicate Comparison
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Conceptra Biosciences, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CCT-101.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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