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

Early Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06228118
• Other study ID #: IHC-3000-LCFA01
• Status: Completed
• Start date: August 4, 2023
• Est. completion date: September 2, 2023

Study information

• Verified date: January 2024
• Source: Andon Health Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: September 2, 2023
• Est. primary completion date: September 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Pregnancy

Locations

Country	Name	City	State
China	First Teaching hospital of Tianjin University of Traditional Chinese Medicine	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Andon Health Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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