AI-Guided TURBT for Bladder Cancer

NCT07727343 | Not Yet Recruiting DMC

• 1 other identifier: ZS-AI based navigation
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Time Frame: Up to 24 months post-surgery

Secondary Outcomes (6)

• Surgical Duration

  Day of surgery (intraoperative)

• Intraoperative Blood Loss

  Day of surgery (intraoperative

• Perioperative Bleeding Rate

  Up to 14 days post-surgery

• Number of Lesions Detected Intraoperatively

  Day of surgery (intraoperative)

• Postoperative Residual Lesion Rate

  Up to 3 months post-surgery

Study Arms (2)

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.

Device: AI Navigation Planning System

Interventions

AI Navigation Planning System DEVICE

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.

AI-navigation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jiajun Wang, MD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Lingzhi Du, MD

CONTACT

+86-19839759960; 20301050222@fudan.edu.cn

Jiajun Wang, MD

CONTACT

+86-15201926887; wang.hang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share