Large Algorithm Setting and Validation Study (NCT07607470)
A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Segal Trials — North Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
- Nanopath Vaginitis Assay (DIAGNOSTIC_TEST)
- BD Max™ Vaginal Panel (DIAGNOSTIC_TEST)
- Cepheid Xpert® Xpress MVP (DIAGNOSTIC_TEST)
- Hologic Aptima® BV Assay (DIAGNOSTIC_TEST)
- Yeast Culture (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Segal Trials — North Miami, Florida
- LSU-CrescentCare Sexual Health Center — New Orleans, Louisiana
📞 Contact the Study Coordinator
Phone: (347) 678-6542
Email: akaplan@segaltrials.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.