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Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
NCT05889195 · View on ClinicalTrials.gov ↗
Study Summary
It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that cannot be seen with the naked eye). This is because the risk of disease (bladder cancer - urothelial carcinoma) is relatively low in this population group, approximately 3%. Invasive procedures such as cystoscopy can cause anxiety and pain, in addition to other potential side effects. This has resulted in low admittance for cystoscopy among patients with hematuria (blood in urine) in urology clinics. Therefore, there is a need for a simpler, non-invasive test that can accurately detect the presence or absence of disease (urothelial carcinoma) in patients with microscopic hematuria. Cxbladder, a non-invasive, urine-based test, has the potential to fill this role.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Cxbladder urine test
Study Locations (4)
California
- Tri Valley Urology Medical Group — Murrieta
New York
- AccuMed Research Associates — Garden City
North Carolina
- Durham VA Health Care System — Durham
Texas
- The Urology Place — San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2023-11-02 |
| Est. Completion | 2026-03-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05889195
The ClinicalTrials.gov registry entry for NCT05889195 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacific Edge Limited, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which Cxbladder urine test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05889195 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, New York, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05889195 about?
NCT05889195 is a clinical study titled "Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria". It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is appropriate for patients with microscopic hematuria (blood in the urine that...
What is the current status of trial NCT05889195?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2023-11-02. Estimated completion is 2026-03-31.
What conditions does trial NCT05889195 study?
This clinical trial studies the following conditions: Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05889195?
The interventions under investigation include: Cxbladder urine test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05889195?
This trial is sponsored by Pacific Edge Limited, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05889195 being conducted?
This trial has 4 study locations across California, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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