Clinical Trial

Comparative Performance of a Vaginal Yeast Test

Recruiting
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Summary
The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-10-14.
Status change: Not Yet Recruiting → Recruiting 2024-05-14
Trial Details
NCT Number NCT05079711
Lead Sponsor Uniformed Services University of the Health Sciences
Collaborators: Savvyon Diagnostics Ltd.
Conditions Vulvovaginal Candidiasis
Enrollment 1,200 participants
Start Date 2022-03-18
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2024-05-16