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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Bladder Cancer

Treatments: Procedure: En-Bloc Resection of Bladder Tumours

Study type: Interventional

Funder types: Other

Identifiers

NCT06281080

CRE2023.589-T

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment arm

Experimental group

Description:

Patients underwent En-Bloc Resection of Bladder Tumours using Agilis Robotic System.

Treatment:

Procedure: En-Bloc Resection of Bladder Tumours