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Recruiting NCT06281080

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

No phase Interventional Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: En-Bloc Resection of Bladder Tumours.
Who it may be relevant to
Registry conditions: Bladder Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Successful en-bloc tumour resection by the robotic system [Time frame: During the operation]
Secondary outcome measures (9)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Shatin

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. PMID 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 fa PMID 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. PMID 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. PMID 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. PMID 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. PMID 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):54 PMID 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. PMID 26776561

Identifiers

NCT: NCT06281080 · CRE2023.589-T

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗