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NCT06394869 · ClinicalTrials.gov registry record · NA
Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
A NA study of Hematuria - Cause Not Known, sponsored by Pacific Edge Limited.
- Recruiting
- Registry status
- NA
- Development phase
- 1,000
- Enrollment target
- 15
- Study locations
NCT06394869: Recruiting NA study of Hematuria - Cause Not Known, sponsored by Pacific Edge Limited.
NCT06394869 is a NA study of Hematuria - Cause Not Known that is actively recruiting participants, run by Pacific Edge Limited. The registered enrollment target is 1,000 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06394869, a NA study of Hematuria - Cause Not Known, is actively recruiting participants, sponsored by Pacific Edge Limited.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,000 participants
- Enrollment target
- 15
- Study locations
Study Summary
This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest worries, it is only found in few of these patients. Most microhematuria patients will have a cystoscopy to look inside the bladder. During a cystoscopy, a small camera is inserted into the bladder. This is done through the urethra, the tube that passes urine from the bladder to the outside. In some patients it can cause pain or anxiety. Not all patients have a cystoscopy. Those that don't, usually return for a urine sample within 6 months. This is done to check if there is still blood in their urine. This study is conducted to find out if the use of "Cxbladder Triage Plus" changes the number of cystoscopies in microhematuria patients. Cxbladder Triage Plus is also called "Triage Plus". It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder. Urothelial carcinoma is by far the most common type of bladder cancer. For the test, the patient voids some urine into a cup. A laboratory then checks the urine of specific genetic material. Abnormalities can be a sign of urothelial carcinoma. The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients. The study is done to find out how Triage Plus changes the number of cystoscopies. Study participants first void urine into a cup. The urine is used for the Triage Plus test. The patients are then assigned to one of two groups. The assignment is random. This means the nobody can influence the assignment. The chance to be assigned to either group is the same. In the test group, the urologist will receive the Triage Plus result and discuss it with the patient. Together they decide whether to do a cystoscopy. In the control group, the
Primary Outcome
Difference in the proportion of cystoscopies performed in each arm.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Cxbladder Triage Plus
Study Locations (15)
New York
- Albany MED Health System - Albany
- Integrated Medical Professionals - New York
- Premier Medical Group of the Hudson Valley, P. C. - Poughkeepsie
Alabama
- Urology Centers of Alabama - Homewood
- Urology Associates of Mobile - Mobile
Tennessee
- Urology Associates, P. C. - Nashville
- Vanderbilt University Medical Center - Nashville
Florida
- Advanced Urology Institute - Daytona Beach - Daytona Beach
Indiana
- Urologic Specialists of Northwest Indiana - Merrillville
Louisiana
- Southern Urology - Lafayette
Maryland
- Chesapeake Urology Research Associates - Hanover
New Jersey
- Summit Health - Voorhees Township
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2025-04-29 |
| Est. Completion | 2027-03 |
| Phase | NA |
What NCT06394869 shows while recruiting
NCT06394869 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Hematuria - Cause Not Known appearing as the primary indexed condition, and to 1 intervention - of which Cxbladder Triage Plus is the first listed.
NCT06394869 lists 15 locations in 11 states (New York, Alabama, Tennessee).
Frequently Asked Questions
What is clinical trial NCT06394869 about?
NCT06394869 is a clinical study titled "Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.". This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest...
What is the current status of trial NCT06394869?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2025-04-29. Estimated completion is 2027-03.
What conditions does trial NCT06394869 study?
This clinical trial studies the following conditions: Hematuria - Cause Not Known.
What interventions are being tested in trial NCT06394869?
The interventions under investigation include: Cxbladder Triage Plus (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06394869?
This trial is sponsored by Pacific Edge Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06394869 being conducted?
This trial has 15 study locations across Alabama, Florida, Indiana, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06394869's enrollment target sits among peer trials
1,000 107th of 2000 higher than 1,880 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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