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Large Algorithm Setting and Validation Study

Recruitingn/aAges 18 Years - anyFemaleNanopath, Inc
NCT07607470 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay. The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.

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📋 Eligibility rules (as published)
Inclusion Criteria: Biologically female participants, ≥ 18 years of age, with at least one of the following symptoms of vaginitis: * Abnormal vaginal discharge * Vaginal or vulvar itching, burning, or irritation * Painful or uncomfortable intercourse * Vaginal odor * Painful or frequent urination Exclusion Criteria: * Participants who do not meet the above-described inclusion criteria will be excluded from the study. * Previously enrolled in this study * Contraindication to vaginal swab sampling
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What it tests

  • Nanopath Vaginitis Assay
  • BD Max™ Vaginal Panel
  • Cepheid Xpert® Xpress MVP
  • Hologic Aptima® BV Assay
  • Yeast Culture
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Where

2 sites
Segal Trials
North Miami, United States
LSU-CrescentCare Sexual Health Center
New Orleans, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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