Recruiting NCT06281080

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

Bladder / Urothelial CancerN/A

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: Bladder Cancer

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)

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.