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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06228118

Enrollment

502

Registered

2024-01-29

Start date

2023-08-04

Completion date

2023-09-02

Last updated

2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Pregnancy

Brief summary

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Method comparison study

Exclusion criteria

* Female； * 18-55 years of age； * Voluntary and sign informed consent form. 2. 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.

Design outcomes

Primary

Measure	Time frame	Description
Comparison results	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

Measure	Time frame	Description
Evaluate the usability and user comprehension of investigational device	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.

Countries

China

Outcome results