Large Algorithm Setting and Validation Study (LAVA)

May 20, 2026 updated by: Nanopath, Inc

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an observational, diagnostic study.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • LSU-CrescentCare Sexual Health Center
        • Contact:
        • Principal Investigator:
          • Rebecca Lillis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The intended use population will be up to 1000 symptomatic participants with a clinical presentation consistent with vaginitis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vaginal Infections (BV, CV, TV)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanopath, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAVA Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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