CClinicalTrials.gg
Status unknownNCT03575286Updated Jul 10, 2018

Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy

An observational study in Pregnancy Related, sponsored by Voyant Diagnostics, Inc.. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-10.

Sponsored by Voyant Diagnostics, Inc. · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
123
Ages
18 Years to 45 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Pregnancy Related

Keywords

  • Pregnancy
  • Urine Testing
  • Medical Diagnostics
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In context

Lead sponsor

This is the only study on the registry with Voyant Diagnostics, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Female patients of childbearing age

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, and teenagers)
  • Prisoners
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
123 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Pregnant female

    Patient has been determined pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University.

    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.

    Diagnostic Test: Pregnancy test

Interventions

  • Diagnostic testPregnancy test

    Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Time of collection - 1 month post collection

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Study locations

1 of 1 sites recruiting
  • Northwestern University
    Chicago, Illinois 60611, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03575286
Lead sponsor
Voyant Diagnostics, Inc.
Collaborators
Northwestern University
Responsible party
Sponsor
First posted
Jul 2, 2018
Start date
Jun 28, 2018
Primary completion
Mar 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Jul 10, 2018

Study contacts

Michael Tu, MS, BS
Contact
michael.tu@voyant.health
214-415-4288
Claire Y Zhou, BA
Contact
claire.zhou@voyant.health
949-355-3695
MaryEllen Pavone, MD, MSCI
principal investigator · Northwestern University, Department of Obstetrics and Gynecology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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