An observational study in Early Pregnancy, sponsored by Andon Health Co., Ltd. Completed at 1 site in China. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Andon Health Co., Ltd · Observational
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.
Andon Health Co., Ltd is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Method comparison study exclusion criteria
Lay user study inclusion criteria
Exclusion Criteria:
Method comparison study exclusion criteria
Lay user study inclusion criteria
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.
Time frame: 30minute
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.
Time frame: 30minute
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Andon Health Co., Ltd