Can an AI camera on a catheter spot bladder cancer better than standard scopes?
NCT ID NCT07095751
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
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2028
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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Prince of Wales Hospital
Hong Kong, Hong Kong
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- Can age predict bladder cancer treatment success?
- Can a Bladder-Instilled drug plus immunotherapy beat High-Risk bladder cancer?