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

Not Applicable

Not yet recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT07095751
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a single-arm study investigating the safety, feasibility and diagnostic performance of AI-assisted Uro-Cam catheter assessment that will be performed at the Prince of Wales Hospital. All patients who are referred to the urology outpatient clinic for hematuria workup, and bladder cancer patients who require follow-up cystoscopy, will be screened for study eligibility. If eligible, patients will be recruited into the study with a proper informed consent. All recruited patients will undergo the AI-assisted Uro-Cam catheter assessment followed by a conventional flexible cystoscopy. The study will be conducted in accordance with the Declaration of Helsinki, and it will be registered in ClinicalTrials.gov.

An AI-assisted Uro-Cam catheter assessment will be arranged for all recruited study subjects. After the AI-assisted Uro- Cam catheter assessment, a conventional flexible cystoscopy will be conducted in the same session. Biopsy will be taken from any suspicious lesion detected upon AI-assisted Uro-Cam catheter assessment or conventional flexible cystoscopy.

After all the procedures, an End-of-study visit will be arranged 4-6 weeks later. The primary outcomes include 30-day complications, and the technical success rate of the AI-assisted Uro-Cam catheter assessment. 30-day complications will be assessed and grading according to the Clavien-Dindo classification. Technical success is defined by the completion of the whole Uro-Cam catheter assessment. The secondary outcomes include the AUC, sensitivity, specificity, positive predictive value, and negative predictive value in detecting histologically confirmed bladder cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-30
• Study Start: 2025-07-31
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-08-03
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
30-day complications	Thirty days after the allocated treatment	30-day complications will be assessed and grading according to the Clavien-Dindo classification.
Technical success rate	Immediately post-operative	Technical success is defined by the completion of the whole Uro-Cam catheter assessment.

Secondary Outcome Measures

Name	Time	Method
Performance Evaluation	Thirty days after the allocated treatment	AUC, sensitivity, specificity, positive predictive value and negative predictive value in detecting bladder cancer will also be evaluated and recorded.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong