Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer

Launched by CHINESE UNIVERSITY OF HONG KONG · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new way to help doctors detect bladder cancer using a special camera combined with artificial intelligence (AI). The AI-assisted Uro-Cam catheter assessment is a procedure where a small camera is inserted into the bladder to look for signs of cancer, and the AI helps analyze what the camera sees. This study aims to find out if this new method is safe, works well, and can accurately identify bladder cancer compared to the usual flexible cystoscopy, which is the standard camera test currently used.

Adults who have blood in their urine (either visible or found in lab tests), unusual cells found in urine tests, or who have a history of a certain type of bladder cancer may be eligible to join. Participants will first have the AI-assisted camera test, followed immediately by the standard camera exam. If any suspicious areas are found during either test, a small tissue sample may be taken for further analysis. After these procedures, there will be a follow-up visit 4 to 6 weeks later to check for any side effects or issues. This study is currently not recruiting yet and will include adults aged 18 and older, of any gender, who meet the health criteria. It is important to know that people with certain heart or lung problems, infections, bleeding issues, or other active cancers will not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or above
• • Fulfil any one of the following three criteria: (1) Macroscopic haematuria or persistent microscopic haematuria (microscopic haematuria in at least two urine tests), (2) Abnormal urine cytology results (Atypical cells in at least two urine cytology tests, OR Suspicious cells or malignant cells in at least one urine cytology test), (3)History of non-muscle-invasive bladder cancer with complete transurethral resection of bladder tumour performed
• Exclusion Criteria:
• • Presence of clinically significant cardiovascular disease (History of acute myocardial infarction, presence of uncontrolled angina within 3 months before screening, New York Heart Association Class III or IV congestive heart failure, presence of ventricular arrhythmias, or presence of second-degree or third-degree heart block)
• • Any evidence of active urinary tract infection
• • Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
• • ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities)
• • History of bleeding disorder or use of anti-coagulants
• • Presence of other active malignancy
• • Pregnancy