AI-Guided TURBT for Bladder Cancer

Sponsor
Fudan University
Study ID
NCT07727343
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: control
    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.
  • Experimental: AI-navigation
    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.

Primary Outcome Measure

Recurrence-Free Survival (RFS) [ Time Frame: Time Frame: Up to 24 months post-surgery ]

Central Contacts

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