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NCT07727343
AI-Guided TURBT for Bladder Cancer
Conditions: Bladder Cancer
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 170
Sponsor: Fudan University
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.
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.
Source: ClinicalTrials.gov (NCT07727343). StuddyBuddy aggregates publicly available trial information.