Bladder Cancer
Conditions
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.
Interventions
PROCEDUREEn-Bloc Resection of Bladder Tumours
Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.
Sponsors
Agilis Robotics Limited
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful en-bloc tumour resection by the robotic system | During the operation | The number of cases completed the intervention by robotic system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total procedure time | During operation | Time from insertion of the robotic system into urethra until removal of the specimen from the body |
| Surgeon Console time | During operation | From the time start of any procedure to completion of urethral catheter insertion |
| Presence of detrusor muscle in specimen | During operation | Presence of detrusor muscle in specimen |
| Resection Margin | During operation | Number of subject with Negative resection margin |
| Dissection time and speed | During operation | Time required for submucosal dissection from the first cut |
| Post-operative complications | Within 90 days after the study intervention | Complication is defined according to the Clavien-Dindo Classification |
| Need of bladder irrigation | Within 30 days after the study intervention. | Number of subject |
| Residual tumour or upstaging of tumour after second look TURBT | Within 30 days after the study intervention. | Number of subject |
| Intra-operative bladder perforation event | During operation | Number of subject |
Countries
Hong Kong
Contacts
Primary ContactChi Fai NG, MD
Outcome results
None listed