NCT07607470 Large Algorithm Setting and Validation Study
| NCT ID | NCT07607470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanopath, Inc |
| Condition | Bacterial Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-06-03 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-06-03 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07607470 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Bacterial Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07607470 currently recruiting?
Yes, NCT07607470 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nanopath, Inc to inquire about joining.
Where is the NCT07607470 trial being conducted?
This trial is being conducted at North Miami, United States, New Orleans, United States.
Who is sponsoring the NCT07607470 clinical trial?
NCT07607470 is sponsored by Nanopath, Inc. The trial plans to enroll 1,000 participants.