[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648945":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":12,"responsibleParty":38,"collaborators":12,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":12,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":12,"overallStatus":62,"whyStopped":12,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":12},{"fullName":5,"class":6},"Fudan University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"control","NO_INTERVENTION","Participants in the control group undergo conventional Transurethral Resection of Bladder Tumor (TURBT) following standard clinical guidelines. The surgeon determines tumor margins and resection range based solely on white-light cystoscopy findings and personal clinical experience, without the use of the AI navigation planning system. All perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical to that of the experimental group.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"AI-navigation","EXPERIMENTAL","Participants in the experimental group undergo standard TURBT with the assistance of the AI navigation planning system. During surgery, the real-time cystoscopic video is processed by the system, which automatically identifies suspicious tumor regions and dynamically displays recommended resection margins as visual overlays on the surgical monitor. The surgeon integrates this AI-generated information with clinical judgment to determine the final resection plan, with the ultimate decision-making authority remaining with the surgeon at all times. All perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical to that of the control group.",[18],"Device: AI Navigation Planning System",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"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 accuracy of 97% and an AUC of 0.97 in multi-center validation. It is designed to assist surgeons in achieving more complete tumor resection by reducing reliance on subjective visual assessment alone. The system operates locally on a standard workstation without requiring internet connectivity, ensuring data security.",[14],[26],{"name":27,"affiliation":5,"role":28},"Jiajun Wang, MD","STUDY_DIRECTOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Lingzhi Du, MD","CONTACT","+86-19839759960","20301050222@fudan.edu.cn",{"name":27,"role":32,"phone":36,"phoneExt":12,"email":37},"+86-15201926887","wang.hang@zs-hospital.sh.cn",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Du Lingzhi","Principal Investigator","100648945","ai-guided-turbt-for-bladder-cancer-100648945",false,"NCT07727343","AI-Guided TURBT for Bladder Cancer","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","AITURBT","Inclusion Criteria:\n\n* Age between 18 and 75 years, male or female.\n* Clinical or imaging diagnosis of non-muscle invasive bladder cancer (NMIBC) according to international diagnostic standards (CT, MRI, ultrasound, cystoscopy).\n* Medically fit for TURBT surgery, with normal or essentially normal renal, cardiopulmonary, and hepatic function.\n* Willing and able to provide written informed consent (signed by the patient or a legally authorized representative).\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Severe dysfunction of other vital organs (heart, lungs, kidneys, etc.).\n* Imaging evidence of distant metastases.\n* Severe infection or active inflammation.\n* Psychiatric disorders or inability to comply with study procedures.\n* Any other condition deemed by the investigator as inappropriate for participation.","ALL","18 Years","75 Years",{"count":54,"type":55},170,"ESTIMATED","INTERVENTIONAL",[58],"NA","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.",[61],"Bladder Cancer","NOT_YET_RECRUITING","2026-07-23",{"date":65,"type":66},"2026-07-27","ACTUAL",{"date":68,"type":55},"2026-08-01",{"date":70,"type":55},"2028-11-30",{"name":5,"class":6}]