Can an AI camera on a catheter spot bladder cancer better than standard scopes?

NCT ID NCT07095751

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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)

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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

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Status unknown
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First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This pilot study is testing whether an artificial intelligence-assisted catheter camera system, called Uro-Cam, can safely and accurately detect bladder cancer. Adults with blood in their urine, abnormal urine cytology, or a history of non-muscle-invasive bladder cancer will undergo the AI-assisted exam followed by a standard flexible cystoscopy. The study will measure technical success, 30-day complications, and how well the AI system identifies cancer compared to biopsy results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-assisted Uro-Cam catheter assessment system
What this could lead to
If successful, this AI-assisted camera system could offer a more accurate and less invasive way to detect bladder cancer during routine exams.
What could go wrong
This is a small pilot study with only 60 participants, so results may not apply to all patients. The device is still experimental and its accuracy compared to standard cystoscopy is not yet proven.

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 60 people

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

Expected to start

Jul 2028

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Age 18 years or above * Fulfil any one of the following three criteria: (1) Macroscopic haematuria or persistent microscopic haematuria (microscopic haematuria in at least two urine tests), (2) Abnormal urine cytology results (Atypical cells in at least two urine cytology tests, OR Suspicious cells or malignant cells in at least one urine cytology test), (3)History of non-muscle-invasive bladder cancer with complete transurethral resection of bladder tumour performed Exclusion Criteria: * Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block) * Any evidence of active urinary tract infection * Presence of GOLD Stage III or IV chronic obstructive pulmonary disease * ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities) * History of bleeding disorder or use of anti-coagulants * Presence of other active malignancy * Pregnancy

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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

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  3. A doctor treating you

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Contacts and locations

Locations

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

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