Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Renal Stone

Treatments: Procedure: Flexible Ureteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06660914

CRE-2024.217

Details and patient eligibility

About

This is a prospective randomized clinical trial which aims to compare the clinical outcomes of robotic flexible ureteroscopy and standard flexible ureteroscopy for the treatment of renal stones.

Full description

This is a prospective randomized controlled trial comparing robotic flexible ureteroscopy and standard flexible ureteroscopy for patients with treatment of renal stones. All consecutive patients who are scheduled for flexible ureteroscopy for treatment of renal stones would be screened for study eligibility. Patients are randomised to receive either robotic or standard flexible ureteroscopy with an allocation ratio of 1:1. by computer generated random block. The urologist performing the surgery could not be blinded due to the nature of the intervention. Patients receiving the treatment and investigators assessing for any disease recurrence are blinded from the allocated treatment arm.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old with informed consent
• Being willing and able to provide written informed consent

Exclusion criteria

• Patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture)
• American Society of Anesthesiologists (ASA) physical status classification system >3
• Untreated urinary tract infection
• Renal stones > 3cm in diameter

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Robotic flexible ureteroscopy with ILY® Robot platform

Experimental group

Description:

Robotic ILY® is a flexible ureteroscopy holder with multiple degrees of freedom telemanipulated with a wireless controller. This allows the surgeon to work easily at a distance from the patient and prevents them from exposing to the source of ionizing radiation.

Treatment:

Procedure: Flexible Ureteroscopy

Standard flexible ureteroscopy

Active Comparator group

Description:

Standard flexible ureterscopy

Treatment:

Procedure: Flexible Ureteroscopy