Clinical trial · Interventional
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
NCT06281080CI-TRIAL-00085584recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| En-Bloc Resection of Bladder Tumours | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.
- interventionNames
- Procedure: En-Bloc Resection of Bladder Tumours
Primary outcomes (1)
- measure
- Successful en-bloc tumour resection by the robotic system
- timeFrame
- During the operation
- description
- The number of cases completed the intervention by robotic system
Secondary outcomes (9)
- measure
- Dissection time and speed
- timeFrame
- During operation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (12)
- BACKGROUNDMaurice 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
- BACKGROUNDGontero 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. PMID 25043942
- BACKGROUNDUkai 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
- BACKGROUNDPaciotti 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
- BACKGROUNDCheng 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
- BACKGROUNDZhang 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.