AI-Guided TURBT for Bladder Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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

Первичные конечные точки

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

Вторичные конечные точки (6)

• Surgical Duration [Срок оценки: Day of surgery (intraoperative)]
• Intraoperative Blood Loss [Срок оценки: Day of surgery (intraoperative]
• Perioperative Bleeding Rate [Срок оценки: Up to 14 days post-surgery]
• Number of Lesions Detected Intraoperatively [Срок оценки: Day of surgery (intraoperative)]
• Postoperative Residual Lesion Rate [Срок оценки: Up to 3 months post-surgery]
• Surgery-Related Complication Rate [Срок оценки: Up to 30 days post-surgery]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07727343 · ZS-AI based navigation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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