Actively Recruiting
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
Led by Chinese University of Hong Kong · Updated on 2025-02-06
10
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
A
Agilis Robotics Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Body mass index less than 35 kg/m2
- Bladder tumour smaller than 3 cm and clinically non-muscle invasive
- Clinically recommended for en-bloc resection
- Willing and able to give informed consent
You will not qualify if you...
- Signs of detrusor muscle invasion on endoscopy or imaging
- Contraindications to general or spinal anesthesia
- American Society of Anesthesiologists (ASA) score greater than 2
- Severe illnesses that shorten life expectancy or increase treatment risk
- Untreated active infections
- Uncorrected bleeding disorders
- Presence of other malignancies or distant metastases
- Emergency surgery
- Vulnerable populations such as mentally disabled or pregnant individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Shatin, Hong Kong
Actively Recruiting
Research Team
C
Chi Fai NG, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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