Trials / Completed
CompletedNCT06228118
Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 502 (actual)
- Sponsor
- Andon Health Co., Ltd · Industry
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Timeline
- Start date
- 2023-08-04
- Primary completion
- 2023-09-02
- Completion
- 2023-09-02
- First posted
- 2024-01-29
- Last updated
- 2024-01-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06228118. Inclusion in this directory is not an endorsement.