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NCT Number: NCT07607470

Large Algorithm Setting and Validation Study

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Segal Trials, North Miami, Florida, United States

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About this study

This is an observational, diagnostic study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nanopath Vaginitis Assay

Diagnostic Test

Investigational Device

BD Max™ Vaginal Panel

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

  1. Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections

    Time frame: 1 day

    Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis

Secondary outcomes

  1. Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay

    Time frame: 1 day

    Compare the performance between clinician-collected samples and self-collected samples using the Nanopath assay for diagnosing vaginitis.

Sponsors and collaborators

Lead sponsor

Nanopath, Inc

Industry

Registry information

Official study title

A Non-Significant Risk Specimen Collection Study to Obtain Vaginal Swab Samples for Algorithm Development and Testing

Acronym: LAVA

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 26, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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