Condition: Bacterial Infections · Bacterial Infections and Mycoses · Infections · Sponsor: Nanopath, Inc
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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| Segal Trials | North Miami, Florida, United States | Recruiting |
| LSU-CrescentCare Sexual Health Center | New Orleans, Louisiana, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07607470