NCT07095751Not yet recruiting
Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer
Pilot Study on Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- 1 Jul 2028
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Bladder cancer
- NCT number
- NCT07095751
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Jul 2028 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Any evidence of active urinary tract infection
- Presence of GOLD Stage III or IV chronic obstructive pulmonary disease
- History of bleeding disorder or use of anti-coagulants
- Presence of other active malignancy
Other
- ECOG performance status ≥ 2 (Ambulatory and capable of all self-care but unable to carry our any work activities)
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.