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NCT06951009
Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men
NA trial testing Colli-Pee in Urethritis in 20 participants. Completed in 7 May 2025.
7 May 2025
Quick facts
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 20 |
| Start date | 9 April 2025 |
| Primary completion | 7 May 2025 |
| Estimated completion | 7 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Colli-Pee
- standard of care 60 mL urine cup
- Urinalysis
- Sysmex UP-5000
Conditions studied
- Urethritis — all drugs for Urethritis →
- Healthy Men Age 18-50 With no Urethral Symptoms — all drugs for Healthy Men Age 18-50 With no Urethral Symptoms →
Sponsor
Indiana University
Who can join
Adults 18 to 50, male only, with Urethritis or Healthy Men Age 18-50 With no Urethral Symptoms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06951009
- Europe PMC full search
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Other Indiana University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06951009 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Indiana University
- Last refreshed: 18 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06951009.
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