Recruiting

Nanopath Assay

Sponsor:

Nanopath, Inc

Code:

NCT07607470

Conditions

Bacterial Infections

Bacterial Infections and Mycoses

Infections

Vaginitis

Vaginal Diseases

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nanopath Vaginitis Assay

BD Max™ Vaginal Panel

Cepheid Xpert® Xpress MVP

Hologic Aptima® BV Assay

Yeast Culture

Study Details

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.

Conditions

Bacterial Infections

Bacterial Infections and Mycoses

Infections

Vaginitis

Vaginal Diseases

Study ID

NCT07607470

Start date

Jun 3, 2026

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Vaginal Infections (BV, CV, TV)

Interventions

Nanopath Vaginitis Assay

Investigational Device

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.

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.

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.

Yeast Culture

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

Primary outcome measure

  • Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections [ Time Frame: 1 day ]

Central Contacts and Locations

Locations

Segal Trials

Recruiting

North Miami, Florida, United States, 33161

Contacts

Anna Kaplan

347-678-6542akaplan@segaltrials.com

Principal Investigator:

Steven Chavoustie, MD, FACOG, CCRP

LSU-CrescentCare Sexual Health Center

Recruiting

New Orleans, Louisiana, United States, 70119

Contacts

Catherine Cammarata

504-568-4132ccamma@lsuhsc.edu

Principal Investigator:

Rebecca Lillis, MD

More Information

Sponsor

Nanopath, Inc

Last update posted

Jul 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nanopath, Inc on 2026-07-20.