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AI eye on bladder cancer: could a smart navigation system help surgeons remove tumors more completely?

NCT ID NCT07727343

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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)

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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This trial tests whether an artificial intelligence system can help surgeons better see and remove bladder tumors during a standard procedure called TURBT. The AI analyzes the live video from the surgical camera and highlights suspicious areas and recommended cutting edges on the surgeon's screen. About 170 people with non-muscle invasive bladder cancer will be randomly assigned to receive either standard surgery or surgery with this AI guidance. The main question is whether the AI-assisted approach can reduce the chance of the cancer coming back after surgery.

What this could mean

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

Active substance
an AI navigation planning system that overlays tumor boundaries on the surgical video feed during bladder tumor removal
What this could lead to
If it works, this AI tool could help surgeons remove bladder tumors more completely, potentially lowering the risk of cancer returning after surgery.
What could go wrong
This is a single-center trial with 170 people, so results may not apply broadly. The AI system's guidance might not improve outcomes over standard surgery, and technical issues could arise during use.

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 170 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 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 to 75 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: * Age between 18 and 75 years, male or female. * Clinical or imaging diagnosis of non-muscle invasive bladder cancer (NMIBC) according to international diagnostic standards (CT, MRI, ultrasound, cystoscopy). * Medically fit for TURBT surgery, with normal or essentially normal renal, cardiopulmonary, and hepatic function. * Willing and able to provide written informed consent (signed by the patient or a legally authorized representative). Exclusion Criteria: * Pregnant or lactating women. * Severe dysfunction of other vital organs (heart, lungs, kidneys, etc.). * Imaging evidence of distant metastases. * Severe infection or active inflammation. * Psychiatric disorders or inability to comply with study procedures. * Any other condition deemed by the investigator as inappropriate for participation.

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Bladder cancer

How to take part

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

  1. 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 ↗

  2. 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.

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