Using a robotic system to remove bladder tumors
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
This study is testing a new robotic system to see if it can safely and effectively remove small bladder tumors in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT06281080 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of a novel robotic system, Zenith, for performing transurethral en-bloc resection of bladder tumors. It is a prospective, single-arm trial that focuses on patients with clinically non-muscle invasive bladder tumors that are less than 3 cm in size. Participants will undergo the en-bloc resection procedure, and the outcomes will be assessed to determine the effectiveness of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with non-muscle invasive bladder tumors under 3 cm.
Not a fit: Patients with muscle-invasive bladder tumors or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a less invasive and more effective treatment option for patients with bladder cancer.
How similar studies have performed: While this approach is novel, similar robotic-assisted techniques have shown promise in other surgical fields, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Shatin
- Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Chi Fai NG, MD — Chinese University of Hong Kong
- Study coordinator: Chi Fai NG, MD
- Email: ngcf@surgery.cuhk.edu.hk
- Phone: 35052625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.