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

NCT06228118 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 502

Last updated 2024-01-30

No results posted yet for this study

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

Sponsors & Collaborators

  • Andon Health Co., Ltd

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2023-09-02
Completion
2023-09-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06228118 on ClinicalTrials.gov