NCT06281080 First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
| NCT ID | NCT06281080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-11-20 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Chi Fai NG, MD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06281080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06281080 currently recruiting?
Yes, NCT06281080 is actively recruiting participants. Contact the research team at ngcf@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT06281080 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT06281080 clinical trial?
NCT06281080 is sponsored by Chinese University of Hong Kong. The principal investigator is Chi Fai NG, MD at Chinese University of Hong Kong. The trial plans to enroll 10 participants.
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