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Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test

Sponsor
Guangzhou Wondfo Biotech Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04207554
Collaborator
Nova Clinical Solutions, Inc. (Other)
132
Enrollment
6
Locations
12.8
Actual Duration (Months)
22
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.

Condition or Disease Intervention/Treatment Phase
  • Device: Test Device-Strip Format
  • Device: Test Device-Cassette Format
  • Device: Predicate Device

Study Design

Study Type:
Observational
Actual Enrollment :
132 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
Actual Study Start Date :
Dec 5, 2019
Actual Primary Completion Date :
Dec 29, 2020
Actual Study Completion Date :
Dec 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Pregnancy Positive

Pregnant subjects within 11 weeks since the first day of last period.

Device: Test Device-Strip Format
Sponsor's investigational device
Other Names:
  • Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format

    • Device: Test Device-Cassette Format
    Sponsor's investigational device
    Other Names:
  • Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format

    • Device: Predicate Device
    Commercially available device
    Other Names:
  • QuickVue+ hCG Combo Test

    		•
    Pregnancy Negative

    Non-pregnant subjects.

    Device: Test Device-Strip Format
    Sponsor's investigational device
    Other Names:
  • Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format

    • Device: Test Device-Cassette Format
    Sponsor's investigational device
    Other Names:
  • Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format

    • Device: Predicate Device
    Commercially available device
    Other Names:
  • QuickVue+ hCG Combo Test

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall percent (%) agreement [3 months]

      The primary endpoint is the overall percent (%) agreement, which is the percentage of total subjects where the test (Preview® hCG Urine/Serum Combo Pregnancy Test) and the reference test (QuickVue+ hCG Combo Test) agree.

    Secondary Outcome Measures

    1. Positive and negative percent agreement [3 months]

      The secondary endpoint is the positive percent agreement and negative percent agreement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy adult women of childbearing age.

    • Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.

    • Signed and dated informed consent.

    Exclusion Criteria:

    • Minors.

    • Adults who are unable to independently give consent for study.

    • Known pregnancy (i.e. - patient appears obviously pregnant).

    • Recent miscarriage or abortion and yet to have 2 complete menstrual cycles before study start.

    • History of ectopic pregnancy, fibroids, congenital uterine anomaly that causes an irregular-shaped uterus.

    • Taken any of the medications of contraceptives containing estrogen in last two weeks.

    • Hemodynamically unstable.

    • Moderately to severely ill-appearing or in moderate to severe pain.

    • Technically not possible to obtain blood or urine from the study subject.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Insitute of Clinical Research Garden Grove California United States 92844
    2 National Research Institute-Huntington Park Huntington Park California United States 90255
    3 Downtown L.A. Research Center, Inc Los Angeles California United States 90017
    4 National Research Institute-Westlake Los Angeles California United States 90057
    5 National Research Institute-Panorama City Panorama City California United States 91402
    6 National Research Institute-Santa Ana Santa Ana California United States 92704

    Sponsors and Collaborators

    • Guangzhou Wondfo Biotech Co., Ltd
    • Nova Clinical Solutions, Inc.

    Investigators

    • Study Chair: Rui Liu, Master, Guangzhou Wondfo Biotech Co., Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangzhou Wondfo Biotech Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT04207554
    Other Study ID Numbers:
    • WF2019-01
    First Posted:
    Dec 23, 2019
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Guangzhou Wondfo Biotech Co., Ltd
    Pregnancy
    hCG
    IVD
    POCT

    Study Results

    No Results Posted as of Jan 11, 2021