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Bladder CancerNCT07095751

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

A study testing AI Uro-Cam in people with Bladder Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
AI Uro-Cam
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteHong Kong
Study dates
1 Jul 2028to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jeremy Yuen Chun TEOH, MBBS, FRCSEd contact

+852 35052625

jeremyteoh@surgery.cuhk.edu.hk

Hong Kong1 site
  • Prince of Wales Hospital

    Hong Kong

    Jeremy Yuen Chun TEOH, MBBS, FRCSEd, +852 35052625, jeremyteoh@surgery.cuhk.edu.hk

    Sui Yan LAU, +852 35053933, beckylau@surgery.cuhk.edu.hk

Other trials in Hong Kong

About this study

Official title: Pilot Study on Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder Cancer

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.

Conditions
Bladder Cancer
Being tested
AI Uro-Cam
Keywords
AI, Uro-Cam, Bladder Cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI Uro-CamDevice

    As stated in AI Uro-Cam arm description

Study groups in NCT07095751
Study groupRoleWhat they receive
AI Uro-CamExperimentalAll recruited patients will undergo the AI-assisted Uro-Cam catheter assessment followed by a conventional flexible cystoscopy in the same session. Biopsy will be taken from any suspicious lesion detected upon AI-assisted Uro-Cam catheter assessment or conventional flexible cystoscopy.
Receives: Device: AI Uro-Cam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day complications

    30-day complications will be assessed and grading according to the Clavien-Dindo classification.

    Measured: Thirty days after the allocated treatment

  2. Technical success rate

    Technical success is defined by the completion of the whole Uro-Cam catheter assessment.

    Measured: Immediately post-operative

Secondary outcomes (1)
  1. Performance Evaluation

    AUC, sensitivity, specificity, positive predictive value and negative predictive value in detecting bladder cancer will also be evaluated and recorded.

    Measured: Thirty days after the allocated treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start1 Jul 2028 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
This is a pilot study investigating the safety, feasibility and diagnostic performance of AI-assisted Uro-Cam catheter assessment.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07095751
Sponsor's protocol ID
CRE 2025.323
Status last verified
Jul 2026
First submitted
23 Jul 2025
Last updated
28 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Britton JP, Dowell AC, Whelan P. Dipstick haematuria and bladder cancer in men over 60: results of a community study. BMJ. 1989 Oct 21;299(6706):1010-2. doi: 10.1136/bmj.299.6706.1010.

    PubMed 2511941
  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009
  • Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.

    PubMed 28128970
  • Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Circulation. 2018 Feb 27;137(9):961-972. doi: 10.1161/CIRCULATIONAHA.117.033502.

    PubMed 29483172
  • Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Thanh Hai MT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034. doi: 10.1016/j.jacc.2017.12.048.

    PubMed 29495982
  • Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

    PubMed 38572751
  • Bastacky S, Ibrahim S, Wilczynski SP, Murphy WM. The accuracy of urinary cytology in daily practice. Cancer. 1999 Jun 25;87(3):118-28. doi: 10.1002/(sici)1097-0142(19990625)87:33.0.co;2-n.

    PubMed 10385442
  • Chan ES, Ng CF, Hou SM, Yip SK. Using urine microscopy and cytology for early detection of bladder cancer in male patients with lower urinary tract symptoms. Int Urol Nephrol. 2011 Jun;43(2):289-94. doi: 10.1007/s11255-010-9856-y. Epub 2010 Nov 4.

    PubMed 21053072
  • Sharp VJ, Barnes KT, Erickson BA. Assessment of asymptomatic microscopic hematuria in adults. Am Fam Physician. 2013 Dec 1;88(11):747-54.

    PubMed 24364522
  • Ritchie CD, Bevan EA, Collier SJ. Importance of occult haematuria found at screening. Br Med J (Clin Res Ed). 1986 Mar 8;292(6521):681-3. doi: 10.1136/bmj.292.6521.681.

    PubMed 3081223
  • Babjuk M, Burger M, Capoun O, Cohen D, Comperat EM, Dominguez Escrig JL, Gontero P, Liedberg F, Masson-Lecomte A, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Seisen T, Soukup V, Sylvester RJ. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022 Jan;81(1):75-94. doi: 10.1016/j.eururo.2021.08.010. Epub 2021 Sep 10.

    PubMed 34511303
  • Peterson LM, Reed HS. Hematuria. Prim Care. 2019 Jun;46(2):265-273. doi: 10.1016/j.pop.2019.02.008. Epub 2019 Apr 1.

    PubMed 31030828
  • Roth V, Espino-Grosso P, Henriksen CH, Canales BK. Office Cystoscopy Urinary Tract Infection Rate and Cost before and after Implementing New Handling and Storage Practices. Urol Pract. 2021 Jan;8(1):23-29. doi: 10.1097/UPJ.0000000000000162. Epub 2020 May 27.

    PubMed 37145433
  • Khadhouri S, Gallagher KM, MacKenzie KR, Shah TT, Gao C, Moore S, Zimmermann EF, Edison E, Jefferies M, Nambiar A, Mannas MP, Lee T, Marra G, Lillaz B, Gomez Rivas J, Olivier J, Assmus MA, Ucar T, Claps F, Boltri M, Burnhope T, Nkwam N, Tanasescu G, Boxall NE, Downey AP, Lal AA, Anton-Juanilla M, Clarke H, Lau DHW, Gillams K, Crockett M, Nielsen M, Takwoingi Y, Chuchu N, O'Rourke J, MacLennan G, McGrath JS, Kasivisvanathan V; IDENTIFY Study group. The IDENTIFY study: the investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer - a multicentre observational study. BJU Int. 2021 Oct;128(4):440-450. doi: 10.1111/bju.15483. Epub 2021 Sep 8.

    PubMed 33991045
  • O'Connor E, McVey A, Demkiw S, Lawrentschuk N, Murphy DG. Assessment and management of haematuria in the general practice setting. Aust J Gen Pract. 2021 Jul;50(7):467-471. doi: 10.31128/AJGP-03-21-5892.

    PubMed 34189542

Questions about this trial

What is this clinical trial studying?

A study testing AI Uro-Cam in people with Bladder Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeremy Yuen Chun TEOH, MBBS, FRCSEd (+852 35052625, jeremyteoh@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day complications (time frame: Thirty days after the allocated treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07095751, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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