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

NCT06281080 | Recruiting

• 1 other identifier: CRE2023.589-T
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Successful en-bloc tumour resection by the robotic system

  The number of cases completed the intervention by robotic system

  During the operation

Secondary Outcomes (9)

• Dissection time and speed

  During operation

• Total procedure time

  During operation

• Surgeon Console time

  During operation

• Presence of detrusor muscle in specimen

  During operation

• Resection Margin

  During operation

Study Arms (1)

Treatment arm

EXPERIMENTAL

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

Procedure: En-Bloc Resection of Bladder Tumours

Interventions

En-Bloc Resection of Bladder Tumours PROCEDURE

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

Treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Agilis Robotics Limited: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Publications (12)

• 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.

  PMID: 22390750 BACKGROUND

• 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.

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• 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.

  PMID: 10687997 BACKGROUND

• 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.

  PMID: 34337509 BACKGROUND

• 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.

  PMID: 30589047 BACKGROUND

• 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.

  PMID: 28683751 BACKGROUND

• 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.

  PMID: 32389447 BACKGROUND

• 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.

  PMID: 26776561 BACKGROUND

• 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.

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MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Chi Fai NG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Fai NG, MD

CONTACT

35052625; ngcf@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: November 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)