Bladder CancerAITURBTNCT07727343
AI-Guided TURBT for Bladder Cancer
A study testing AI Navigation Planning System in people with Bladder Cancer, run by Fudan University.
Trial summary
This prospective, randomized, controlled, single-center study evaluates whether an AI navigation planning system used during Transurethral Resection of Bladder Tumor (TURBT) can improve recurrence-free survival in patients with non-muscle invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- AI Navigation Planning System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Efficacy and Safety of an AI Navigation Planning System in Transurethral Resection of Bladder Tumor: A Prospective, Randomized, Controlled, Single-Center Study
This prospective, randomized, controlled, single-center study evaluates whether an AI navigation planning system used during Transurethral Resection of Bladder Tumor (TURBT) can improve recurrence-free survival in patients with non-muscle invasive bladder cancer. Participants are randomized to receive either standard TURBT surgery or standard TURBT with AI-assisted real-time tumor identification and resection margin guidance. The primary outcome is recurrence-free survival, with secondary outcomes including surgical duration, intraoperative blood loss, perioperative bleeding, and complication rates. The study aims to provide high-level evidence on the clinical utility of AI-assisted surgical navigation in bladder cancer treatment.
- Conditions
- Bladder Cancer
- Being tested
- AI Navigation Planning System
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Navigation Planning SystemDevice
The AI Navigation Planning System is a software-based medical device that processes real-time video from a standard cystoscope during TURBT. It uses deep learning algorithms to automatically identify suspicious tumor regions and perform semantic segmentation of tumor boundaries on the endoscopic video stream. The system overlays the identified tumor areas and dynamically recommended resection margins onto the surgical monitor as visual guidance for the surgeon. The system achieves a diagnostic accuracy of 97% and an AUC of 0.97 in multi-center validation. It is designed to assist surgeons in achieving more complete tumor resection by reducing reliance on subjective visual assessment alone. The system operates locally on a standard workstation without requiring internet connectivity, ensuring data security.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Participants in the control group undergo conventional Transurethral Resection of Bladder Tumor (TURBT) following standard clinical guidelines. The surgeon determines tumor margins and resection range based solely on white-light cystoscopy findings and personal clinical experience, without the use of the AI navigation planning system. All perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical to that of the experimental group. |
| AI-navigation | Experimental | Participants in the experimental group undergo standard TURBT with the assistance of the AI navigation planning system. During surgery, the real-time cystoscopic video is processed by the system, which automatically identifies suspicious tumor regions and dynamically displays recommended resection margins as visual overlays on the surgical monitor. The surgeon integrates this AI-generated information with clinical judgment to determine the final resection plan, with the ultimate decision-making authority remaining with the surgeon at all times. All perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical to that of the control group. Receives: Device: AI Navigation Planning System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
Time from surgery to the first occurrence of tumor recurrence confirmed by imaging (CT/MRI/ultrasound) or cystoscopy with pathological biopsy, or death from any cause, whichever occurs first. Participants without an event at the end of follow-up will be censored at the date of the last known follow-up visit.
Measured: Time Frame: Up to 24 months post-surgery
Secondary outcomes (6)
Surgical Duration
Time from cystoscope entry into the bladder to successful placement of the urinary catheter at the end of surgery, recorded in minutes.
Measured: Day of surgery (intraoperative)
Intraoperative Blood Loss
Total blood loss during surgery, calculated by suction canister fluid minus irrigation fluid plus gauze weighing method, recorded in milliliters (mL).
Measured: Day of surgery (intraoperative
Perioperative Bleeding Rate
Proportion of participants experiencing bleeding requiring interventional therapy, unplanned reoperation, or blood transfusion within 14 days post-surgery.
Measured: Up to 14 days post-surgery
Number of Lesions Detected Intraoperatively
Total number of tumor lesions identified and documented during the surgical procedure.
Measured: Day of surgery (intraoperative)
Postoperative Residual Lesion Rate
Proportion of participants with residual or newly detected lesions at the first postoperative cystoscopy follow-up visit.
Measured: Up to 3 months post-surgery
Surgery-Related Complication Rate
Incidence and severity of postoperative complications graded according to the Clavien-Dindo Classification (Grade I to V) within 30 days post-surgery.
Measured: Up to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated in a 1:1 ratio to either the experimental group (TURBT with AI navigation planning system) or the control group (conventional TURBT without AI assistance). Assignment is parallel, with no crossover between groups. All other perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical between the two groups.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Du Lingzhi, Fudan University
- Investigators
- Jiajun Wang, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727343
- Sponsor's protocol ID
- ZS-AI based navigation
- Acronym
- AITURBT
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to: (1) the informed consent form does not include provisions for sharing individual participant data with external researchers; (2) intraoperative video data contain sensitive patient information that cannot be fully anonymized; (3) institutional data governance policies restrict data sharing beyond the primary study team; and (4) the AI navigation system involves proprietary technology, and the validation dataset requires controlled access to protect intellectual property. Summary-level results will be made available in peer-reviewed publications.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of an AI Navigation Planning System in Transurethral Resection of Bladder Tumor: A Prospective, Randomized, Controlled, Single-Center Study
- ClinicalTrials.gov ID
- NCT07727343
- Acronym / sponsor ID
- AITURBT / ZS-AI based navigation
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized, controlled, single-center study evaluates whether an AI navigation planning system used during Transurethral Resection of Bladder Tumor (TURBT) can improve recurrence-free survival in patients with non-muscle invasive bladder cancer. Participants are randomized to receive either standard TURBT surgery or standard TURBT with AI-assisted real-time tumor identification and resection margin guidance. The primary outcome is recurrence-free survival, with secondary outcomes including surgical duration, intraoperative blood loss, perioperative bleeding, and complication rates. The study aims to provide high-level evidence on the clinical utility of AI-assisted surgical navigation in bladder cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants are randomly allocated in a 1:1 ratio to either the experimental group (TURBT with AI navigation planning system) or the control group (conventional TURBT without AI assistance). Assignment is parallel, with no crossover between groups. All other perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical between the two groups.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Participants in the control group undergo conventional Transurethral Resection of Bladder Tumor (TURBT) following standard clinical guidelines. The surgeon determines tumor margins and resection range based solely on white-light cystoscopy findings and personal clinical experience, without the use of the AI navigation planning system. All perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical to that of the experimental group. |
| AI-navigation | Experimental | Device: AI Navigation Planning SystemParticipants in the experimental group undergo standard TURBT with the assistance of the AI navigation planning system. During surgery, the real-time cystoscopic video is processed by the system, which automatically identifies suspicious tumor regions and dynamically displays recommended resection margins as visual overlays on the surgical monitor. The surgeon integrates this AI-generated information with clinical judgment to determine the final resection plan, with the ultimate decision-making authority remaining with the surgeon at all times. All perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical to that of the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI Navigation Planning SystemThe AI Navigation Planning System is a software-based medical device that processes real-time video from a standard cystoscope during TURBT. It uses deep learning algorithms to automatically identify suspicious tumor regions and perform semantic segmentation of tumor boundaries on the endoscopic video stream. The system overlays the identified tumor areas and dynamically recommended resection margins onto the surgical monitor as visual guidance for the surgeon. The system achieves a diagnostic accuracy of 97% and an AUC of 0.97 in multi-center validation. It is designed to assist surgeons in achieving more complete tumor resection by reducing reliance on subjective visual assessment alone. The system operates locally on a standard workstation without requiring internet connectivity, ensuring data security. | Device | AI-navigation |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: Time Frame: Up to 24 months post-surgery
Time from surgery to the first occurrence of tumor recurrence confirmed by imaging (CT/MRI/ultrasound) or cystoscopy with pathological biopsy, or death from any cause, whichever occurs first. Participants without an event at the end of follow-up will be censored at the date of the last known follow-up visit.
6 secondary outcomes
Surgical Duration
Time frame: Day of surgery (intraoperative)
Intraoperative Blood Loss
Time frame: Day of surgery (intraoperative
Perioperative Bleeding Rate
Time frame: Up to 14 days post-surgery
Number of Lesions Detected Intraoperatively
Time frame: Day of surgery (intraoperative)
Postoperative Residual Lesion Rate
Time frame: Up to 3 months post-surgery
Surgery-Related Complication Rate
Time frame: Up to 30 days post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to: (1) the informed consent form does not include provisions for sharing individual participant data with external researchers; (2) intraoperative video data contain sensitive patient information that cannot be fully anonymized; (3) institutional data governance policies restrict data sharing beyond the primary study team; and (4) the AI navigation system involves proprietary technology, and the validation dataset requires controlled access to protect intellectual property. Summary-level results will be made available in peer-reviewed publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiajun Wang, MD study director
Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing AI Navigation Planning System in people with Bladder Cancer, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingzhi Du, MD (+86-19839759960, 20301050222@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: Time Frame: Up to 24 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.