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NCT06951009 · ClinicalTrials.gov registry record · NA
Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT06951009 is a NA study that has completed, run by Indiana University. The registered enrollment target is 20 participants.
The verdict
NCT06951009, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DIAGNOSTIC_TEST Urinalysis
- DEVICE Colli-Pee
- DEVICE standard of care 60 mL urine cup
- DIAGNOSTIC_TEST Sysmex UP-5000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-04-09 |
| Est. Completion | 2025-05-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06951009
The ClinicalTrials.gov registry entry for NCT06951009 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Urinalysis is the first listed.
NCT06951009 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06951009 about?
NCT06951009 is a clinical study titled "Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men". 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 eviden...
What is the current status of trial NCT06951009?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2025-04-09. Estimated completion is 2025-05-07.
What interventions are being tested in trial NCT06951009?
The interventions under investigation include: Urinalysis (DIAGNOSTIC_TEST), Colli-Pee (DEVICE), standard of care 60 mL urine cup (DEVICE), Sysmex UP-5000 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06951009?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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