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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.
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Inclusion criteria
Method comparison study exclusion criteria
Lay user study inclusion criteria
Exclusion criteria
Method comparison study exclusion criteria
Lay user study inclusion criteria
502 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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