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A drop of urine, a world of difference: new test could spot hidden infections

NCT ID NCT06951009

Diagnosis Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This study is testing whether a new urine analysis device, the Sysmex UF-5000, can accurately measure inflammation markers in healthy men. The goal is to establish a baseline for what's normal, which could help develop a quick, non-invasive test for urethritis, a common infection. Participants will provide urine samples using two different collection methods to see which is more reliable. This is an early step toward a potential point-of-care test that could improve STI diagnosis and treatment.

What this could mean

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

Active substance
Sysmex UF-5000 flow cytometer (diagnostic device) and Colli-Pee urine self-sampling device
What this could lead to
If successful, this could pave the way for a quick, non-invasive urine test to detect urethritis early, improving STI management.
What could go wrong
This is a small, early study in healthy men only, so results may not apply to symptomatic individuals or other populations. The device's accuracy in real-world settings remains to be proven.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Apr 2025

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 50 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Men aged 18 to 50. * No urethral symptoms (discharge, dysuria) Exclusion Criteria: * History of genital surgery or known urethral abnormalities * Testing positive for gonorrhea and chlamydia * Diagnosis of a sexually transmitted infection within the last year. * Not available to collect a urine specimen in the morning 3x/week for 2 weeks

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Conditions

The condition(s) this trial relates to.

urethritis

As listed by the trial registrant

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

Healthy men age 18-50 with no urethral symptoms Urethritis

Contacts and locations

Locations

  • Indiana University

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.