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

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 Overview

• Status: Unknown
• Conditions: Pregnancy Related
• Intervention / Treatment: Diagnostic test: Pregnancy test

• Study Type: Observational
• Enrollment (Anticipated): 123

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: MaryEllen Pavone, MD, MSCI; Phone Number: 312-926-8244; Email: MaryEllen.Pavone@nm.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients of childbearing age

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy
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; Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 of collection - 1 month post collection

Collaborators and Investigators

• Sponsor: Voyant Diagnostics, Inc.
• Collaborators: Northwestern University
• Investigators: Principal Investigator: MaryEllen Pavone, MD, MSCI, Northwestern University, Department of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 7, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy; Urine Testing; Medical Diagnostics
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes