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.

Study Overview

• Status: Completed
• Conditions: Early Pregnancy

• Study Type: Observational
• Enrollment (Actual): 502

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

A total of 502 subjects with ages from 18-55 years old were enrolled . Among the 502 total subjects, 369 subjects aged between 18 and 55 years old voluntarily participated in the Lay User Study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Subjects enrolled in method comparison study only
Subjects enrolled in both the method comparison study and lay user study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison results	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.	30minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the usability and user comprehension of investigational device	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.	30minute

Collaborators and Investigators

• Sponsor: Andon Health Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Actual): September 2, 2023
• Study Completion (Actual): September 2, 2023

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IHC-3000-LCFA01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No