NCT06281080Recruiting
Performance, Feasibility, and Safety Study for a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours: First-In-Human Trial
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 20 Feb 2024
- Start date
- 20 Nov 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Bladder cancer
- NCT number
- NCT06281080
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 20 Nov 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Emergency surgery
Other illness
- Untreated active infection
- Presence of another malignancy or distant metastasis
Other
- Presence of endoscopic or imaging signs of detrusor muscle invasion
- Contraindication to general anaesthesia / spinal anaesthesia
- ASA \> 2 patients
- Un-corrected coagulopathy
- Vulnerable population (e.g. mentally disabled, pregnant)
Who the study is looking for
- Age between 18 and 75 years
- Body mass index \<35 kg/m2
- Bladder tumour located \<3 cm in size; clinically non-muscle invasive bladder tumour
- Clinically indicated for en-bloc resection.
- Willingness to participate as demonstrated by giving informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.