PregnancyNCT06516211
Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test
An observational study of Pregnancy, run by Conceptra Biosciences, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Clara Pregnancy Test and Professional Marketed Pregnancy Test
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2027to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Females over the age of 18, who are capable of becoming pregnant.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
FPA Women's Health
Los Angeles, California, 90022
Regulatory Conceptra, 855-692-5272, info@conceptrabio.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Clara Pregnancy Test, Professional Marketed Pregnancy Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clara Pregnancy TestDevice
Multi-Level Pregnancy Test
Professional Marketed Pregnancy TestDevice
Early Pregnancy Test
| Study group | Role | What they receive |
|---|---|---|
| Lay User | Not described Receives: Device: Clara Pregnancy Test | |
| HCP Predicate Device | Not described Receives: Device: Clara Pregnancy Test; Device: Professional Marketed Pregnancy Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Predicate Comparison
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start30 Jan 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Conceptra Biosciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516211
- Sponsor's protocol ID
- CCT-101.001
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Candidate - Predicate Comparison and Lay User-HCP Comparison Study of the Clara(TM) Multi-Level Urine hCG Pregnancy Test
- ClinicalTrials.gov ID
- NCT06516211
- Acronym / sponsor ID
- CCT-101.001
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Conceptra Biosciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lay User | – | Device: Clara Pregnancy Test |
| HCP Predicate Device | – | Device: Clara Pregnancy Test, Device: Professional Marketed Pregnancy Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Females over the age of 18, who are capable of becoming pregnant.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clara Pregnancy TestMulti-Level Pregnancy Test | Device | HCP Predicate Device, Lay User |
| Professional Marketed Pregnancy TestEarly Pregnancy Test | Device | HCP Predicate Device |
Primary outcome
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 secondary outcome
Predicate Comparison
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Conceptra Biosciences, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regulatory Conceptra (855-692-5272, info@conceptrabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lay-Professional Comparison (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.