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Clinical Trial

Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men

NCT: NCT06951009 · COMPLETED

NCT IDNCT06951009
StatusCOMPLETED
Start Date2025-04-09
Completion2025-05-07
SponsorIndiana University (OTHER)
First posted
Last updated

Brief Summary

Acute urethritis (inflammation of the male urethra) affects millions of men in the United States each year. Effective management of STIs is complicated by asymptomatic infections, as men often delay seeking care until symptoms become severe. Yet, even men without symptoms can show measurable evidence of urethritis. Therefore, a cheap, simple, and non-invasive point-of-care (POC) test, providing results within 30 minutes, could significantly enhance STI management by facilitating early diagnosis and treatment. A new diagnostic method, urine flow cytometry, has shown potential in hospital settings for accurately detecting inflammation by counting white blood cells (infection-fighting cells) in urine samples. The Sysmex UF-5000 flow cytometer, a state-of-the-art device, may offer a non-invasive, cost-effective, and accurate method to diagnose urethritis compared to traditional Gram stains and urinalysis, potentially extending its use beyond specialized clinics. This study aims to determine the efficacy and precision of the Sysmex UF-5000 analyzer in diagnosing urethritis using first-catch urine samples. Additionally, the study seeks to evaluate whether urine collected using the 10 mL Colli-Pee device provides greater accuracy and precision compared to the standard urine cup (30-60 mL) when used with urine flow cytometry and LE urinalysis.

Frequently Asked Questions

What is Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men?

Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men is a clinical trial registered under NCT06951009. Current status: COMPLETED.

What is the status of NCT06951009?

The current status of NCT06951009 (Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men) is: COMPLETED.

When did Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men start?

Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men started on 2025-04-09.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.