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

July 7, 2018 updated by: Voyant Diagnostics, Inc.
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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
Time of collection - 1 month post collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Voyant Diagnostics, Inc.

Collaborators

Northwestern University

Investigators

  • Principal Investigator: MaryEllen Pavone, MD, MSCI, Northwestern University, Department of Obstetrics and Gynecology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 1

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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