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

Chinese University of Hong Kong1 site in 1 country10 target enrollmentNovember 20, 2024

ConditionsBladder Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: Chinese University of Hong Kong
Enrollment: 10
Locations: 1
Primary Endpoint: Successful en-bloc tumour resection by the robotic system
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 20, 2024

End Date

March 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chinese University of Hong Kong

Responsible Party

Principal Investigator

Chi Fai NG

Professor

Chinese University of Hong Kong

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)

Outcomes

Primary Outcomes

Successful en-bloc tumour resection by the robotic system

Time Frame: During the operation

The number of cases completed the intervention by robotic system

Secondary Outcomes

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)
Intra-operative bladder perforation event(During operation)
Post-operative complications(Within 90 days after the study intervention)
Need of bladder irrigation(Within 30 days after the study intervention.)
Residual tumour or upstaging of tumour after second look TURBT(Within 30 days after the study intervention.)