Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
1 other identifier
observational
123
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2018
CompletedStudy Start
First participant enrolled
June 28, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedJuly 10, 2018
July 1, 2018
8 months
June 21, 2018
July 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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
Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy
Eligibility Criteria
Female patients of childbearing age
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Voyant Diagnostics, Inc.lead
- Northwestern Universitycollaborator
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Biospecimen
Urine
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MaryEllen Pavone, MD, MSCI
Northwestern University, Department of Obstetrics and Gynecology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2018
First Posted
July 2, 2018
Study Start
June 28, 2018
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
July 10, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share