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Trial record 70 of 636 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT03575286
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pregnancy Related Diagnostic Test: Pregnancy test

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Study Type : Observational
Estimated Enrollment : 123 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female patients of childbearing age
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575286


Contacts
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Contact: Michael Tu, MS, BS 214-415-4288 michael.tu@voyant.health
Contact: Claire Y Zhou, BA 949-355-3695 claire.zhou@voyant.health

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: MaryEllen Pavone, MD, MSCI    312-926-8244    MaryEllen.Pavone@nm.org   
Sponsors and Collaborators
Voyant Diagnostics, Inc.
Northwestern University
Investigators
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Principal Investigator: MaryEllen Pavone, MD, MSCI Northwestern University, Department of Obstetrics and Gynecology

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Responsible Party: Voyant Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT03575286     History of Changes
Other Study ID Numbers: 1
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Voyant Diagnostics, Inc.:
Pregnancy
Urine Testing
Medical Diagnostics