NCT06516211

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

June 10, 2024

Last Update Submit

March 17, 2026

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Lay-Professional Comparison

    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 Outcomes (1)

  • Predicate Comparison

    1 day

Study Arms (2)

Lay User

Device: Clara Pregnancy Test

HCP Predicate Device

Device: Clara Pregnancy TestDevice: Professional Marketed Pregnancy Test

Interventions

Clara Pregnancy TestDEVICE

Multi-Level Pregnancy Test

HCP Predicate DeviceLay User
Professional Marketed Pregnancy TestDEVICE

Early Pregnancy Test

HCP Predicate Device

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPersons assigned female at birth and not sterile
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FPA Women's Health

Los Angeles, California, 90022, United States

Location

Central Study Contacts

Regulatory Conceptra

CONTACT

855-692-5272info@conceptrabio.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

July 23, 2024

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)