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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07727343). StuddyBuddy aggregates publicly available trial information.