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Comparative Performance of a Vaginal Yeast Test

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Aug 30, 2026 → Oct 30, 2027
See other at-risk trials from Uniformed Services University of the Health Sciences

Record History

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  1. Primary and study completion pushed from Aug 30, 2026 to Oct 30, 2027
    • Trial status changed: Unknown → Active, Not Recruiting
    • Site details revised at 3 of 3 sites
    v3
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Primary and study completion dates: Nov 30, 2022 to Aug 30, 2026v2 Show 5 more changesShow less
    • Start date changed from estimate of Nov 15, 2021 to Mar 18, 2022
    • Trial status: Not Yet Recruiting to Unknown
    • Study sites: 0 to 3
    • Eligibility criteria shortened, about 7 words
    • Study description shortened, about 15 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05079711
Lead Sponsor Uniformed Services University of the Health Sciences
Collaborators: Savvyon Diagnostics Ltd.
Conditions
(from sponsor)		 Vulvovaginal Candidiasis
Related terms Candidiasis, Vulvovaginal
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov