First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours

Not Applicable

Not yet recruiting

• Conditions: Bladder Cancer
• Interventions: Procedure: En-Bloc Resection of Bladder Tumours

• Registration Number: NCT06281080
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Study Start: 2024-12-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	En-Bloc Resection of Bladder Tumours	Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.

Primary Outcome Measures

Name	Time	Method
Successful en-bloc tumour resection by the robotic system	During the operation	The number of cases completed the intervention by robotic system

Secondary Outcome Measures

Name	Time	Method
Dissection time and speed	During operation	Time required for submucosal dissection from the first cut
Presence of detrusor muscle in specimen	During operation	Presence of detrusor muscle in specimen
Post-operative complications	Within 30 days after the study intervention	Complication is defined according to the Clavien-Dindo Classification
Surgeon Console time	During operation	From the time start of any procedure to completion of urethral catheter insertion
Total procedure time	During operation	Time from insertion of the robotic system into urethra until removal of the specimen from the body
Resection Margin	During operation	Number of subject with Negative resection margin
Intra-operative bladder perforation event	During operation	Number of subject
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