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Recruiting No phase listed Observational

Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria

ClinicalTrials.gov ID: NCT05889195

Public ClinicalTrials.gov record NCT05889195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Validation of Cxbladder Triage-Plus for the Detection of Urothelial Carcinoma in Subjects With Microscopic Hematuria (microDRIVE)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05889195
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Pacific Edge Limited
Industry
Enrollment
1,000 participants

Conditions and interventions

Interventions

Diagnostic Test

Eligibility (public fields only)

Age range
18 Years to 89 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 1, 2023
Primary completion
May 30, 2026
Completion
Jun 29, 2026
Last update posted
Apr 23, 2026

2023 – 2026

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Tri Valley Urology Medical Group Murrieta California 92562 Recruiting
AccuMed Research Associates Garden City New York 11530 Recruiting
Durham VA Health Care System Durham North Carolina 27705 Recruiting
The Urology Place San Antonio Texas 78240 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05889195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 23, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05889195 live on ClinicalTrials.gov.

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