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Completed

NCT Number: NCT06228118

Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System

This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.

Lay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.

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Key information

Conditions

Early Pregnancy

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

First Teaching hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Method comparison study exclusion criteria
  • Female；
  • 18-55 years of age；
  • Voluntary and sign informed consent form.
  • Lay user study inclusion criteria
  • Female；
  • 18-55 years of age；
  • Voluntary and sign informed consent form；
  • Willingness to perform self-test of investigational device；
  • Have the ability to read English.

Exclusion criteria

  • Method comparison study exclusion criteria
  • Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
  • Within 8 weeks of childbirth or abortion；
  • The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
  • Lay user study inclusion criteria
  • Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
  • Within 8 weeks of childbirth or abortion；
  • The investigator has reason to believe that it is inappropriate for subjects to participate in the study；
  • Background in a medical or laboratory testing.

Treatment and study plan

Primary outcomes

  1. Comparison results

    Time frame: 30minute

    Compare the test results conducted by professionals using investigational device and the comparator, and the positive percent agreement (PPA=100%), negative percent agreement (NPA=100%) and overall percent agreement (OPA=100%) were calculated.

Secondary outcomes

  1. Evaluate the usability and user comprehension of investigational device

    Time frame: 30minute

    The accuracy rate of the critical task is 100%. The Overall Percent Agreement for investigational device is 100% when conducted by a lay user. The accuracy rate of the each questions in the Knowledge assessment is 100%, and 100% of the Ease of operation assessment chose normal, easy, or very easy.

Sponsors and collaborators

Lead sponsor

Andon Health Co., Ltd

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 29, 2024
Registry last updated
Jan 30, 2024

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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