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Trial Title:
First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
NCT ID:
NCT06281080
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
En-Bloc Resection of Bladder Tumours
Description:
Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.
Arm group label:
Treatment arm
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.
Criteria for eligibility:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 1, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Agilis Robotics Limited
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06281080
