Prince of Wales Hospital
Shatin, Hong Kong
Location status: Recruiting
Recruiting
NCT Number: NCT06281080
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- Presence of endoscopic or imaging signs of detrusor muscle invasion
- Contraindication to general anaesthesia / spinal anaesthesia
- ASA > 2 patients
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Untreated active infection
- Un-corrected coagulopathy
- Presence of another malignancy or distant metastasis
- Emergency surgery
- Vulnerable population (e.g. mentally disabled, pregnant)
Treatment and study plan
En-Bloc Resection of Bladder Tumours
ProcedurePatients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.
Primary outcomes
-
Successful en-bloc tumour resection by the robotic system
Time frame: During the operation
The number of cases completed the intervention by robotic system
Secondary outcomes
-
Dissection time and speed
Time frame: During operation
Time required for submucosal dissection from the first cut
-
Total procedure time
Time frame: During operation
Time from insertion of the robotic system into urethra until removal of the specimen from the body
-
Surgeon Console time
Time frame: During operation
From the time start of any procedure to completion of urethral catheter insertion
-
Presence of detrusor muscle in specimen
Time frame: During operation
Presence of detrusor muscle in specimen
-
Resection Margin
Time frame: During operation
Number of subject with Negative resection margin
-
Intra-operative bladder perforation event
Time frame: During operation
Number of subject
-
Post-operative complications
Time frame: Within 90 days after the study intervention
Complication is defined according to the Clavien-Dindo Classification
-
Need of bladder irrigation
Time frame: Within 30 days after the study intervention.
Number of subject
-
Residual tumour or upstaging of tumour after second look TURBT
Time frame: Within 30 days after the study intervention.
Number of subject
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Chinese University of Hong Kong
Other
Collaborators
- Agilis Robotics Limited
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Feb 28, 2024
- Registry last updated
- Feb 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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