Pregnancy RelatedNCT03575286
Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
An observational study of Pregnancy Related, run by Voyant Diagnostics, Inc. at 1 site in United States.
Trial summary
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Pregnancy test
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female patients of childbearing age
Who may be able to join
- Patient age 18 years and older, upper age limit of 45 years
- Female patient
- Patients undergoing any procedures for pregnancy diagnosis and confirmation
- English speaking
- The following special population will be included:
- Pregnant women
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, and teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
MaryEllen Pavone, MD, MSCI, 312-926-8244, MaryEllen.Pavone@nm.org
About this study
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Our hypothesis is that this automated point-of-care urine diagnostic device will be able to accurately determine a patient's pregnancy status at least 95% of the time.
- Conditions
- Pregnancy Related
- Being tested
- Pregnancy test
- Keywords
- Pregnancy, Urine Testing, Medical Diagnostics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy testDiagnostic test
Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Pregnant female | Patient has been determined pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University. Receives: Diagnostic Test: Pregnancy test | |
| Non-pregnant female | Patient has been determined not pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University. Receives: Diagnostic Test: Pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy in determining pregnancy status
Compare qualitative pregnancy test results generated by Voyant's device with urine pregnancy test result(s) and, if applicable, serum pregnancy test results performed at Northwestern University. From this comparison, we will determine the accuracy of Voyant's device. We will be using the same urine sample used at Northwestern.
Measured: Time of collection - 1 month post collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start28 Jun 2018
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Voyant Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- MaryEllen Pavone, MD, MSCI, Principal investigator, Northwestern University, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575286
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2018
- First submitted
- 21 Jun 2018
- Last updated
- 10 Jul 2018
- 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 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
- ClinicalTrials.gov ID
- NCT03575286
- Acronym / sponsor ID
- 1
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Urine Testing, Medical Diagnostics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Voyant Diagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 2 Jul 2018 (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.
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Our hypothesis is that this automated point-of-care urine diagnostic device will be able to accurately determine a patient's pregnancy status at least 95% of the time.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant female | – | Diagnostic Test: Pregnancy testPatient has been determined pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University. |
| Non-pregnant female | – | Diagnostic Test: Pregnancy testPatient has been determined not pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female patients of childbearing age
Key inclusion criteria (6 listed)
- Patient age 18 years and older, upper age limit of 45 years
- Female patient
- Patients undergoing any procedures for pregnancy diagnosis and confirmation
- English speaking
- Pregnant women
Key exclusion criteria (3 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, and teenagers)
- Prisoners
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 |
|---|---|---|
| Pregnancy testDetects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy | Diagnostic test | Non-pregnant female, Pregnant female |
Primary outcome
Accuracy in determining pregnancy status
Time frame: Time of collection - 1 month post collection
Compare qualitative pregnancy test results generated by Voyant's device with urine pregnancy test result(s) and, if applicable, serum pregnancy test results performed at Northwestern University. From this comparison, we will determine the accuracy of Voyant's device. We will be using the same urine sample used at Northwestern.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- 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. This study is not recruiting at the moment.
MaryEllen Pavone, MD, MSCI principal investigator
Northwestern University, Department of Obstetrics and Gynecology
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 Related, run by Voyant Diagnostics, Inc. 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Tu, MS, BS (214-415-4288, michael.tu@voyant.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy in determining pregnancy status (time frame: Time of collection - 1 month post collection). 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 10 Jul 2018.