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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03575286
• Other study ID #: 1
• Status: Recruiting
• Start date: June 28, 2018
• Est. completion date: March 2019

Study information

• Verified date: July 2018
• Source: Voyant Diagnostics, Inc.
• Contact: Michael Tu, MS, BS
• Phone: 214-415-4288
• Email: michael.tu[@]voyant.health
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Diagnostic Test:
• Pregnancy test
Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Voyant Diagnostics, Inc.	Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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