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

Last updated: February 4, 2025
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urothelial Carcinoma

Urothelial Cancer

Bladder Cancer

Treatment

En-Bloc Resection of Bladder Tumours

Clinical Study ID

NCT06281080
CRE2023.589-T
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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

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 increasesrisk 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 Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: En-Bloc Resection of Bladder Tumours
Phase:
Study Start date:
November 20, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Prince of Wales Hospital

    Sha Tin,
    Hong Kong

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.