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

Status unconfirmed

Conditions studied: Pregnancy Related

In brief

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.

Key facts

Study ID

NCT03575286

Run by

Voyant Diagnostics, Inc.

People needed

123

Starts

2018-06-28

Expected to finish

2019-03-01

Last updated by the study team

2018-07-10

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Northwestern University — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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