Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones

May 4, 2025 updated by: NG Chi Fai, Chinese University of Hong Kong

A Randomized Controlled Trial Comparing Robotic Flexible Ureteroscopy With Standard Flexible Ureteroscopy for Treatment of Renal Stones - A Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Sheung Shui, Hong Kong
        • Recruiting
        • North District Hospital
        • Contact:
        • Sub-Investigator:
          • Steffi Kar Kei YUEN, FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic flexible ureteroscopy with ILY® Robot platform
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.
Procedure: Flexible Ureteroscopy
Ureteroscopic lithotripsy
Active Comparator: Standard flexible ureteroscopy
Standard flexible ureterscopy
Procedure: Flexible Ureteroscopy
Ureteroscopic lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone-free rate at 1 month
Time Frame: Month 1
Stone-free rate at 1 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments <2mm
Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone-free rate at 3 month
Time Frame: Month 3
If not stone free at 1 month, stone-free rate at 3 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments <2mm
Month 3
Operative time
Time Frame: During operation
the time from insertion of an endoscope into the urethra to the completion of stent placement
During operation
Lasing Time
Time Frame: During operation
The total lasing time in minutes during operation
During operation
Total laser energy used
Time Frame: During operation
Total laser energy used during operation
During operation
Total radiation dose
Time Frame: During operation
Total radiation dose during operation
During operation
Total radiation time
Time Frame: during operation
total radiation time in minutes during operation
during operation
Length of hospital stay
Time Frame: On Discharge
defined from the day of surgery to the day of discharge, counted in days.
On Discharge
Postoperative pain
Time Frame: Baseline, Week 1 and Week 12
By visual analogue scores from 0-10, the highest score the more pain.
Baseline, Week 1 and Week 12
Surgeon radiation exposure
Time Frame: During operation
By radiation dosimeter
During operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 3, 2026

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2024.217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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