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

Completed

• Conditions: Early Pregnancy

• Registration Number: NCT06228118
• Lead Sponsor: Andon Health Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-04
• Primary Completion: 2023-09-02
• Study Completion: 2023-09-02
• Status Verified: 2024-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-28
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 502

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.

Exclusion Criteria

1. 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.

2. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

First Teaching hospital of Tianjin University of Traditional Chinese Medicine; 🇨🇳 Tianjin, China