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Fast new swab test could speed up vaginitis diagnosis

NCT ID NCT07607470

Diagnosis Sponsor: Nanopath, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study will test a new diagnostic device called the Nanopath assay, which aims to quickly detect bacteria or yeast causing vaginitis. Up to 1000 women with symptoms like itching or discharge will provide vaginal swab samples, either collected by a clinician or themselves. The goal is to see how well the new test compares to existing FDA-cleared tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nanopath Vaginitis Assay (diagnostic test)
What this could lead to
If successful, this could provide a faster, simpler test for diagnosing vaginal infections, potentially improving treatment decisions.
What could go wrong
This is an early pilot study focused on algorithm development, not a treatment trial. The test may not prove accurate enough or may not be adopted in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Bacterial Infections and Mycoses bacterial infectious disease bacterial vaginosis candidiasis female reproductive system disorder Female Urogenital Diseases fungal infectious disease Infections infectious disease trichomoniasis Urogenital Diseases vaginal disorder vaginitis vulvar disease vulvovaginal candidiasis vulvovaginitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacterial infections Bacterial infections and mycoses Candidiasis Female urogenital diseases Genital diseases, female Infections Mycoses Urogenital disease Vaginal diseases Vaginitis Vaginosis, bacterial Vulvar diseases Vulvovaginitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • LSU-CrescentCare Sexual Health Center

    RECRUITING

    New Orleans, Louisiana, 70119, United States

  • Segal Trials

    RECRUITING

    North Miami, Florida, 33161, United States

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