Clinical trial NCT06281080: First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
Official title: First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Agilis Robotics Limited
First posted: 2024-02-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Successful en-bloc tumour resection by the robotic system
timeFrame: During the operation
Secondary outcomes:
measure: Dissection time and speed
timeFrame: During operation
measure: Total procedure time
timeFrame: During operation
measure: Surgeon Console time
timeFrame: During operation
measure: Presence of detrusor muscle in specimen
timeFrame: During operation
measure: Resection Margin
timeFrame: During operation
measure: Intra-operative bladder perforation event
timeFrame: During operation
measure: Post-operative complications
timeFrame: Within 90 days after the study intervention
measure: Need of bladder irrigation
timeFrame: Within 30 days after the study intervention.
measure: Residual tumour or upstaging of tumour after second look TURBT
timeFrame: Within 30 days after the study intervention.
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
References:
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