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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281080
• Other study ID #: CRE2023.589-T
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Chi Fai NG, MD
• Phone: 35052625
• Email: ngcf[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Agilis Robotics Limited

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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