AI-Guided TURBT for Bladder Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI Navigation Planning System.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device AI Navigation Planning System
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 a
Primary outcome measures
- Recurrence-Free Survival (RFS) [Time frame: Time Frame: Up to 24 months post-surgery]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07727343 · ZS-AI based navigation