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

RECRUITINGN/ASponsored by Chinese University of Hong Kong
Actively Recruiting
PhaseN/A
SponsorChinese University of Hong Kong
Started2024-11-20
Est. completion2025-12-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06281080

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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)

Conditions2

Bladder CancerCancer

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