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NCT06281080 | NOT YET RECRUITING | Bladder Cancer

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

Chinese University of Hong Kong

Information provided by (Responsible Party):

Who Do You NG

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.

Condition or disease

Bladder Cancer

Intervention/treatment

En-Bloc Resection of Bladder Tumours

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours

Location Details

NCT06281080

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How to Participate

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