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Large Algorithm Setting and Validation Study

NCT07607470 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

  • Bacterial Infections
  • Bacterial Infections and Mycoses
  • Infections
  • Vaginitis
  • Vaginal Diseases
  • Genital Diseases, Female
  • Female Urogenital Diseases
  • Urogenital Disease
  • Candidiasis
  • Mycoses
  • Vulvovaginitis
  • Vulvar Diseases
  • Vaginosis, Bacterial

Interventions

DIAGNOSTIC_TEST

Nanopath Vaginitis Assay

Investigational Device

DIAGNOSTIC_TEST

BD Max™ Vaginal Panel

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.

DIAGNOSTIC_TEST

Cepheid Xpert® Xpress MVP

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.

DIAGNOSTIC_TEST

Hologic Aptima® BV Assay

This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.

DIAGNOSTIC_TEST

Yeast Culture

Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.

Sponsors & Collaborators

  • Nanopath, Inc

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07607470 on ClinicalTrials.gov