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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: En-Bloc Resection of Bladder Tumours

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chi Fai Ng, MD; Phone Number: 35052625; Email: ngcf@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Sha Tin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Chi Fai NG, MD; Phone Number: 3505 2625; Email: ngcf@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of endoscopic or imaging signs of detrusor muscle invasion
2. Contraindication to general anaesthesia / spinal anaesthesia
3. ASA > 2 patients
4. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
5. Untreated active infection
6. Un-corrected coagulopathy
7. Presence of another malignancy or distant metastasis
8. Emergency surgery
9. Vulnerable population (e.g. mentally disabled, pregnant)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm; Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.	Procedure: En-Bloc Resection of Bladder Tumours; Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful en-bloc tumour resection by the robotic system	The number of cases completed the intervention by robotic system	During the operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Agilis Robotics Limited
• Investigators: Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CRE2023.589-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No