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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

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)

Study details
    Bladder Cancer

NCT06281080

Chinese University of Hong Kong

15 October 2025

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