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Urine test may spare thousands from painful bladder scopes

NCT ID NCT06394869

Diagnosis Sponsor: Pacific Edge Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study looks at 1,000 adults who have microscopic blood in their urine (microhematuria), which can be a sign of bladder cancer. Currently, many need a cystoscopy—a camera inserted into the bladder—which can be uncomfortable. The study tests whether a urine test called Cxbladder Triage Plus can safely lower the number of cystoscopies by helping doctors decide who really needs one. Half the participants' doctors will see the test result; the other half will follow standard care. Researchers will compare how many cystoscopies are done in each group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 88 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient is referred for assessment of recent hematuria, defined as either: 1. Microscopic hematuria (≥3 RBC/HPF or equivalent) on urine microscopy obtained within 180 days prior to enrollment, OR 2. Hematuria detected by dipstick analysis (≥2+ blood or equivalent) at referral and confirmed on the same calendar day and prior to enrollment, with urine microscopy collected on the same day as enrollment 2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered. 3. Able to give informed, written consent. 4. Able and willing to comply with study requirements. 5. Must be 19 or the legal age of consent in the jurisdiction in which the study is taking place to 88 years of age inclusive, at the time of signing the informed consent. 6. Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend Spanish with access to an English-Spanish interpreter for all study related verbal instructions and discussions. Exclusion Criteria: 1. Prior history of bladder malignancy. 2. Prior history of upper tract UC or prostatic urethral UC. 3. History of gross hematuria requiring instrumentation or hospitalization within the last 12 months 4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch) 5. Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture). 6. Cystoscopy contraindicated due to another condition or anatomy. 7. History of pelvic radiation. 8. Currently receiving systemic chemotherapy or has had systemic chemotherapy within the last 6 weeks. 9. History of schistosomiasis. 10. History of chronic (\>3 months) indwelling Foley catheter or chronic (\>3 months) bladder stones. 11. Known current pregnancy

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Conditions

The condition(s) this trial relates to.

transitional cell carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematuria - cause not known

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Urology Institute - Daytona Beach

    RECRUITING

    Daytona Beach, Florida, 32114, United States

  • Albany MED Health System

    RECRUITING

    Albany, New York, 12208, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • Austin Urology Institute

    NOT_YET_RECRUITING

    Austin, Texas, 78758, United States

  • Chesapeake Urology Research Associates

    RECRUITING

    Hanover, Maryland, 21076, United States

  • Comprehensive Urology

    RECRUITING

    Los Angeles, California, 90048, United States

  • Dayton Physicians Network

    RECRUITING

    Dayton, Ohio, 45409, United States

  • Integrated Medical Professionals

    RECRUITING

    New York, New York, 11042, United States

  • Penn State Medical Center, Urology Research

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

    Contact Email: •••••@•••••

  • Premier Medical Group of the Hudson Valley, P. C.

    RECRUITING

    Poughkeepsie, New York, 12601, United States

  • Southern Urology

    TERMINATED

    Lafayette, Louisiana, 70508, United States

  • Summit Health

    RECRUITING

    Voorhees Township, New Jersey, 08043, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Wisconsin-Madison

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Urologic Specialists of Northwest Indiana

    RECRUITING

    Merrillville, Indiana, 46410, United States

  • Urology Associates of Central California

    RECRUITING

    Fresno, California, 93720, United States

  • Urology Associates of Mobile

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Urology Associates, P. C.

    TERMINATED

    Nashville, Tennessee, 37209, United States

  • Urology Centers of Alabama

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Urology Group of Southern California

    RECRUITING

    Los Angeles, California, 90017-4007, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States