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

Recruiting now · Not applicable

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT06281080

Run by

Chinese University of Hong Kong

People needed

10

Starts

2024-11-20

Expected to finish

2026-03-31

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Prince of Wales Hospital — Shatin, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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