Recruiting

Observational Study

Sponsor:

Voyant Diagnostics, Inc.

Code:

NCT03575286

Conditions

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Pregnancy test

Study Details

Brief 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.

Conditions

Pregnancy Related

Study ID

NCT03575286

Start date

Jun 28, 2018

Status verified date

Jul, 2018

Completion date

Mar, 2019

Anticipated

Primary completion date

Mar, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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:

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

Study Design

Enrollment

123 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant female

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

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.

Interventions

Pregnancy test

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

Primary outcome measure

  • Accuracy in determining pregnancy status [ Time Frame: Time of collection - 1 month post collection ]

Central Contacts and Locations

Central contacts

Michael Tu, MS, BS

214-415-4288michael.tu@voyant.health

Claire Y Zhou, BA

949-355-3695claire.zhou@voyant.health

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

MaryEllen Pavone, MD, MSCI

312-926-8244MaryEllen.Pavone@nm.org

More Information

Sponsor

Voyant Diagnostics, Inc.

Last update posted

Jul 10, 2018

Last verified

Jul, 2018

Keywords

  • Pregnancy
  • Urine Testing
  • Medical Diagnostics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Voyant Diagnostics, Inc. on 2018-07-10.