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RecruitingNot ApplicableNCT06281080

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

Sponsor

Chinese University of Hong Kong

Enrollment

10 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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)

Interventions

PROCEDUREEn-Bloc Resection of Bladder Tumours

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

Locations(1)

Prince of Wales Hospital

Shatin, Hong Kong

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NCT06281080

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