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

• Conditions: Pregnancy Related
• Interventions: Diagnostic Test: Pregnancy test

• Registration Number: NCT03575286
• Lead Sponsor: Voyant Diagnostics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-06-21
• Study Start: 2018-06-28
• Status Verified: 2018-07
• Study First Posted: 2018-07-02
• Last Update Submitted: 2018-07-07
• Last Update Posted: 2018-07-10
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 123

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-pregnant female	Pregnancy test	Patient has been determined not pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University.
Pregnant female	Pregnancy test	Patient has been determined pregnant with a urine pregnancy test and, if applicable, a serum pregnancy test performed at Northwestern University.

Primary Outcome Measures

Name	Time	Method
Accuracy in determining pregnancy status	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States