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Completed

NCT Number: NCT04207554

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

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National Insitute of Clinical Research, Garden Grove, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test Device-Strip Format

Device

Sponsor's investigational device

Other names: Preview® hCG Urine/Serum Combo Pregnancy Test-Strip Format

Test Device-Cassette Format

Device

Sponsor's investigational device

Other names: Preview® hCG Urine/Serum Combo Pregnancy Test-Cassette Format

Predicate Device

Device

Commercially available device

Other names: QuickVue+ hCG Combo Test

Primary outcomes

  1. Overall percent (%) agreement

    Time frame: 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 outcomes

  1. Positive and negative percent agreement

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Guangzhou Wondfo Biotech Co., Ltd

Industry

Collaborators

  • Nova Clinical Solutions, Inc.

Registry information

Acronym: Preview® hCG

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2019
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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