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

NCT06228118 | Completed

• 1 other identifier: IHC-3000-LCFA01
• Study Type: observational
• Target: 502
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the usability and user comprehension of investigational device

  30minute

Study Arms (2)

Subjects enrolled in method comparison study only

Subjects enrolled in both the method comparison study and lay user study

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may not qualify if:

• Female；
• years of age；
• Voluntary and sign informed consent form.
• Female；
• years of age；
• Voluntary and sign informed consent form；
• Willingness to perform self-test of investigational device；
• Have the ability to read English.
• 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.
• 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.

Sponsors & Collaborators

• Andon Health Co., Ltd: lead

Study Sites (1)

First Teaching hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: August 4, 2023
• Primary Completion: September 2, 2023
• Study Completion: September 2, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (1)