Bladder CancerNCT06281080

Performance, Feasibility, and Safety Study for a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours: First-In-Human Trial

A study testing En-Bloc Resection of Bladder Tumours in people with Bladder Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Bladder Cancer
What is being tested?: En-Bloc Resection of Bladder Tumours
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteHong Kong
Study dates: 20 Nov 2024to 31 Mar 2029
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 18 and 75 years
Body mass index <35 kg/m2
Bladder tumour located <3 cm in size; clinically non-muscle invasive bladder tumour
Clinically indicated for en-bloc resection.
Willingness to participate as demonstrated by giving informed consent

Who cannot join

Presence of endoscopic or imaging signs of detrusor muscle invasion
Contraindication to general anaesthesia / spinal anaesthesia
ASA > 2 patients
Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
Untreated active infection
Un-corrected coagulopathy

Show all 9Show fewer

Presence of another malignancy or distant metastasis
Emergency surgery
Vulnerable population (e.g. mentally disabled, pregnant)

Trial locations and contacts

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

Chi Fai NG, MD contact

35052625

ngcf@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting

Prince of Wales Hospital
Shatin
Chi Fai NG, MD, 3505 2625, ngcf@surgery.cuhk.edu.hk
Recruiting

Other trials in Hong Kong

About this study

Official title: First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours

This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.

Conditions: Bladder Cancer
Being tested: En-Bloc Resection of Bladder Tumours
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.

En-Bloc Resection of Bladder TumoursProcedure or surgery
Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.

Study groups in NCT06281080
Study group	Role	What they receive
Treatment arm	Experimental	Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System. Receives: Procedure: En-Bloc Resection of Bladder Tumours

What is being measured

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

Successful en-bloc tumour resection by the robotic system
The number of cases completed the intervention by robotic system
Measured: During the operation

Secondary outcomes (9)

Dissection time and speed
Time required for submucosal dissection from the first cut
Measured: During operation
Total procedure time
Time from insertion of the robotic system into urethra until removal of the specimen from the body
Measured: During operation
Surgeon Console time
From the time start of any procedure to completion of urethral catheter insertion
Measured: During operation
Presence of detrusor muscle in specimen
Presence of detrusor muscle in specimen
Measured: During operation
Resection Margin
Number of subject with Negative resection margin
Measured: During operation
Intra-operative bladder perforation event
Number of subject
Measured: During operation
Post-operative complications
Complication is defined according to the Clavien-Dindo Classification
Measured: Within 90 days after the study intervention
Need of bladder irrigation
Number of subject
Measured: Within 30 days after the study intervention.
Residual tumour or upstaging of tumour after second look TURBT
Number of subject
Measured: Within 30 days after the study intervention.

Timeline

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

20 Nov 202431 Mar 2029

First posted28 Feb 2024
Study start20 Nov 2024
Primary completion31 Dec 2028 (estimated)
Study completion31 Mar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Bladder CancerStudies of the same condition, open and under way.
More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06281080
Sponsor's protocol ID: CRE2023.589-T
Status last verified: Oct 2026
First submitted: 20 Feb 2024
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Maurice MJ, Vricella GJ, MacLennan G, Buehner P, Ponsky LE. Endoscopic snare resection of bladder tumors: evaluation of an alternative technique for bladder tumor resection. J Endourol. 2012 Jun;26(6):614-7. doi: 10.1089/end.2011.0587. Epub 2012 May 3.
PubMed 22390750
Gontero P, Sylvester R, Pisano F, Joniau S, Vander Eeckt K, Serretta V, Larre S, Di Stasi S, Van Rhijn B, Witjes AJ, Grotenhuis AJ, Kiemeney LA, Colombo R, Briganti A, Babjuk M, Malmstrom PU, Oderda M, Irani J, Malats N, Baniel J, Mano R, Cai T, Cha EK, Ardelt P, Varkarakis J, Bartoletti R, Spahn M, Johansson R, Frea B, Soukup V, Xylinas E, Dalbagni G, Karnes RJ, Shariat SF, Palou J. Prognostic factors and risk groups in T1G3 non-muscle-invasive bladder cancer patients initially treated with Bacillus Calmette-Guerin: results of a retrospective multicenter study of 2451 patients. Eur Urol. 2015 Jan;67(1):74-82. doi: 10.1016/j.eururo.2014.06.040. Epub 2014 Jul 16.
PubMed 25043942
Ukai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9.
PubMed 10687997
Paciotti M, Casale P, Colombo P, Fasulo V, Saita A, Lughezzani G, Contieri R, Buffi NM, Lazzeri M, Guazzoni G, Hurle R. Long-term Follow-up After En Bloc Transurethral Resection of Non-muscle-invasive Bladder Cancer: Results from a Single-center Experience. Eur Urol Open Sci. 2021 Feb 24;26:64-71. doi: 10.1016/j.euros.2021.01.015. eCollection 2021 Apr.
PubMed 34337509
Cheng YY, Sun Y, Li J, Liang L, Zou TJ, Qu WX, Jiang YZ, Ren W, Du C, Du SK, Zhao WC. Transurethral endoscopic submucosal en bloc dissection for nonmuscle invasive bladder cancer: A comparison study of HybridKnife-assisted versus conventional dissection technique. J Cancer Res Ther. 2018;14(7):1606-1612. doi: 10.4103/jcrt.JCRT_786_17.
PubMed 30589047
Zhang KY, Xing JC, Li W, Wu Z, Chen B, Bai DY. A novel transurethral resection technique for superficial bladder tumor: retrograde en bloc resection. World J Surg Oncol. 2017 Jul 6;15(1):125. doi: 10.1186/s12957-017-1192-6.
PubMed 28683751
Teoh JY, MacLennan S, Chan VW, Miki J, Lee HY, Chiong E, Lee LS, Wei Y, Yuan Y, Yu CP, Chow WK, Poon DM, Chan R, Lai F, Ng CF, Breda A, Kramer MW, Malavaud B, Mostafid H, Herrmann T, Babjuk M. An International Collaborative Consensus Statement on En Bloc Resection of Bladder Tumour Incorporating Two Systematic Reviews, a Two-round Delphi Survey, and a Consensus Meeting. Eur Urol. 2020 Oct;78(4):546-569. doi: 10.1016/j.eururo.2020.04.059. Epub 2020 May 8.
PubMed 32389447
Hurle R, Lazzeri M, Colombo P, Buffi N, Morenghi E, Peschechera R, Castaldo L, Pasini L, Casale P, Seveso M, Zandegiacomo S, Taverna G, Benetti A, Lughezzani G, Fiorini G, Guazzoni G. "En Bloc" Resection of Nonmuscle Invasive Bladder Cancer: A Prospective Single-center Study. Urology. 2016 Apr;90:126-30. doi: 10.1016/j.urology.2016.01.004. Epub 2016 Jan 14.
PubMed 26776561
Teoh JY, Mayor N, Li KM, Lo KL, Ng CF, Mostafid H. En-bloc resection of bladder tumour as primary treatment for patients with non-muscle-invasive bladder cancer: routine implementation in a multi-centre setting. World J Urol. 2021 Sep;39(9):3353-3358. doi: 10.1007/s00345-021-03675-9. Epub 2021 Mar 28.
PubMed 33774705
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.
PubMed 19782876
McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK; IDEAL Group. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ. 2013 Jun 18;346:f3012. doi: 10.1136/bmj.f3012.
PubMed 23778427
Bilbro NA, Hirst A, Paez A, Vasey B, Pufulete M, Sedrakyan A, McCulloch P; IDEAL Collaboration Reporting Guidelines Working Group. The IDEAL Reporting Guidelines: A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation. Ann Surg. 2021 Jan 1;273(1):82-85. doi: 10.1097/SLA.0000000000004180.
PubMed 32649459

Interested in taking part?

Chi Fai NG, MD

35052625

ngcf@surgery.cuhk.edu.hk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8
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EHR Integrated Remote Patient Monitoring to Reduce Readmission for Patients With Bladder Cancer Undergoing Cystectomy
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RecruitingObservational study
A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States
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All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
ClinicalTrials.gov ID: NCT06281080
Acronym / sponsor ID: CRE2023.589-T
Conditions: Bladder Cancer
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 10 participants (estimated)
Lead sponsor: Chinese University of Hong KongUniversity, hospital or other
Collaborators: Agilis Robotics Limited
Study start: 20 Nov 2024 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Mar 2029 (estimated)
First posted: 28 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment arm	Experimental	Procedure: En-Bloc Resection of Bladder TumoursPatients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age between 18 and 75 years
Body mass index <35 kg/m2
Bladder tumour located <3 cm in size; clinically non-muscle invasive bladder tumour
Clinically indicated for en-bloc resection.
Willingness to participate as demonstrated by giving informed consent

Key exclusion criteria (9 listed)

Presence of endoscopic or imaging signs of detrusor muscle invasion
Contraindication to general anaesthesia / spinal anaesthesia
ASA > 2 patients
Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
Untreated active infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
En-Bloc Resection of Bladder TumoursPatients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.	Procedure or surgery	Treatment arm

Primary outcome

Successful en-bloc tumour resection by the robotic system
Time frame: During the operation
The number of cases completed the intervention by robotic system

9 secondary outcomes

Dissection time and speed
Time frame: During operation
Total procedure time
Time frame: During operation
Surgeon Console time
Time frame: During operation
Presence of detrusor muscle in specimen
Time frame: During operation
Resection Margin
Time frame: During operation
Intra-operative bladder perforation event
Time frame: During operation
Post-operative complications
Time frame: Within 90 days after the study intervention
Need of bladder irrigation
Time frame: Within 30 days after the study intervention.
Residual tumour or upstaging of tumour after second look TURBT
Time frame: Within 30 days after the study intervention.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Background: PubMed 22390750Maurice MJ, Vricella GJ, MacLennan G, Buehner P, Ponsky LE. Endoscopic snare resection of bladder tumors: evaluation of an alternative technique for bladder tumor resection. J Endourol. 2012 Jun;26(6):614-7. doi: 10.1089/end.2011.0587. Epub 2012 May 3.
Background: PubMed 25043942Gontero P, Sylvester R, Pisano F, Joniau S, Vander Eeckt K, Serretta V, Larre S, Di Stasi S, Van Rhijn B, Witjes AJ, Grotenhuis AJ, Kiemeney LA, Colombo R, Briganti A, Babjuk M, Malmstrom PU, Oderda M, Irani J, Malats N, Baniel J, Mano R, Cai T, Cha EK, Ardelt P, Varkarakis J, Bartoletti R, Spahn M, Johansson R, Frea B, Soukup V, Xylinas E, Dalbagni G, Karnes RJ, Shariat SF, Palou J. Prognostic factors and risk groups in T1G3 non-muscle-invasive bladder cancer patients initially treated with Bacillus Calmette-Guerin: results of a retrospective multicenter study of 2451 patients. Eur Urol. 2015 Jan;67(1):74-82. doi: 10.1016/j.eururo.2014.06.040. Epub 2014 Jul 16.
Background: PubMed 10687997Ukai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9.
Background: PubMed 34337509Paciotti M, Casale P, Colombo P, Fasulo V, Saita A, Lughezzani G, Contieri R, Buffi NM, Lazzeri M, Guazzoni G, Hurle R. Long-term Follow-up After En Bloc Transurethral Resection of Non-muscle-invasive Bladder Cancer: Results from a Single-center Experience. Eur Urol Open Sci. 2021 Feb 24;26:64-71. doi: 10.1016/j.euros.2021.01.015. eCollection 2021 Apr.
Background: PubMed 30589047Cheng YY, Sun Y, Li J, Liang L, Zou TJ, Qu WX, Jiang YZ, Ren W, Du C, Du SK, Zhao WC. Transurethral endoscopic submucosal en bloc dissection for nonmuscle invasive bladder cancer: A comparison study of HybridKnife-assisted versus conventional dissection technique. J Cancer Res Ther. 2018;14(7):1606-1612. doi: 10.4103/jcrt.JCRT_786_17.
Background: PubMed 28683751Zhang KY, Xing JC, Li W, Wu Z, Chen B, Bai DY. A novel transurethral resection technique for superficial bladder tumor: retrograde en bloc resection. World J Surg Oncol. 2017 Jul 6;15(1):125. doi: 10.1186/s12957-017-1192-6.
Background: PubMed 32389447Teoh JY, MacLennan S, Chan VW, Miki J, Lee HY, Chiong E, Lee LS, Wei Y, Yuan Y, Yu CP, Chow WK, Poon DM, Chan R, Lai F, Ng CF, Breda A, Kramer MW, Malavaud B, Mostafid H, Herrmann T, Babjuk M. An International Collaborative Consensus Statement on En Bloc Resection of Bladder Tumour Incorporating Two Systematic Reviews, a Two-round Delphi Survey, and a Consensus Meeting. Eur Urol. 2020 Oct;78(4):546-569. doi: 10.1016/j.eururo.2020.04.059. Epub 2020 May 8.
Background: PubMed 26776561Hurle R, Lazzeri M, Colombo P, Buffi N, Morenghi E, Peschechera R, Castaldo L, Pasini L, Casale P, Seveso M, Zandegiacomo S, Taverna G, Benetti A, Lughezzani G, Fiorini G, Guazzoni G. "En Bloc" Resection of Nonmuscle Invasive Bladder Cancer: A Prospective Single-center Study. Urology. 2016 Apr;90:126-30. doi: 10.1016/j.urology.2016.01.004. Epub 2016 Jan 14.
Background: PubMed 33774705Teoh JY, Mayor N, Li KM, Lo KL, Ng CF, Mostafid H. En-bloc resection of bladder tumour as primary treatment for patients with non-muscle-invasive bladder cancer: routine implementation in a multi-centre setting. World J Urol. 2021 Sep;39(9):3353-3358. doi: 10.1007/s00345-021-03675-9. Epub 2021 Mar 28.
Background: PubMed 19782876McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration; Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.
Background: PubMed 23778427McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK; IDEAL Group. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ. 2013 Jun 18;346:f3012. doi: 10.1136/bmj.f3012.
Background: PubMed 32649459Bilbro NA, Hirst A, Paez A, Vasey B, Pufulete M, Sedrakyan A, McCulloch P; IDEAL Collaboration Reporting Guidelines Working Group. The IDEAL Reporting Guidelines: A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation. Ann Surg. 2021 Jan 1;273(1):82-85. doi: 10.1097/SLA.0000000000004180.
Individual participant dataSharing planned: No

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Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Chi Fai NG, MD contact

35052625

ngcf@surgery.cuhk.edu.hk

Chi Fai NG, MD principal investigator

Chinese University of Hong Kong

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing En-Bloc Resection of Bladder Tumours 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Nov 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 Chi Fai NG, MD (35052625, ngcf@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful en-bloc tumour resection by the robotic system (time frame: During the operation). 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 NCT06281080, which also lists 12 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 3 Nov 2026.