AI-Guided TURBT for Bladder Cancer
ConditionBladder Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
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
Qualifiers
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).
Disqualifiers
Pregnant or lactating women.
Severe dysfunction of other vital organs (heart, lungs, kidneys, etc.).
Imaging evidence of distant metastases.
Severe infection or active inflammation.
Trial design
Treatments tested in this trial
- AI Navigation Planning System
Treatment groups
170 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov