NCT06660914

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

October 14, 2024

Last Update Submit

May 4, 2025

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

  • Stone-free rate at 1 month

    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 Outcomes (9)

  • Stone-free rate at 3 month

    Month 3

  • Operative time

    During operation

  • Lasing Time

    During operation

  • Total laser energy used

    During operation

  • Total radiation dose

    During operation

  • +4 more secondary outcomes

Study Arms (2)

Robotic flexible ureteroscopy with ILY® Robot platform

EXPERIMENTAL

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

Standard flexible ureteroscopy

ACTIVE COMPARATOR

Standard flexible ureterscopy

Procedure: Flexible Ureteroscopy

Interventions

Flexible UreteroscopyPROCEDURE

Ureteroscopic lithotripsy

Robotic flexible ureteroscopy with ILY® Robot platformStandard flexible ureteroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North District Hospital

Sheung Shui, Hong Kong

RECRUITING

Related Publications (12)

  • Bravo-Balado A, Fontanet S, Skolarikos A, Gozen AS, Somani BK, Traxer O, Papatsoris A, Ruiz Martinez A, Keller EX, Pietropaolo A, Tonyali S, Tailly T, Esperto F, Liatsikos E, Kanashiro AK, Angerri O, Emiliani E. Estimated Radiation Dose to the Lens During Endourologic Procedures: The Role of Leaded Glasses and the ALARA Protocol-An ESU/ESUT-YAU Endourology Group Collaboration. J Endourol. 2023 Aug;37(8):935-939. doi: 10.1089/end.2023.0061.

    PMID: 37337653BACKGROUND

  • Desai MM, Grover R, Aron M, Ganpule A, Joshi SS, Desai MR, Gill IS. Robotic flexible ureteroscopy for renal calculi: initial clinical experience. J Urol. 2011 Aug;186(2):563-8. doi: 10.1016/j.juro.2011.03.128. Epub 2011 Jun 16.

    PMID: 21683380BACKGROUND

  • Geavlete P, Saglam R, Georgescu D, Multescu R, Iordache V, Kabakci AS, Ene C, Geavlete B; -. Robotic Flexible Ureteroscopy Versus Classic Flexible Ureteroscopy in Renal Stones: the Initial Romanian Experience. Chirurgia (Bucur). 2016 Jul-Aug;111(4):326-9.

    PMID: 27604670BACKGROUND

  • El-Hajj A, Abou Chawareb E, Zein M, Wahoud N. First prospective clinical assessment of the ILY(R) robotic flexible ureteroscopy platform. World J Urol. 2024 Mar 13;42(1):143. doi: 10.1007/s00345-024-04869-7.

    PMID: 38478076BACKGROUND

  • Klein J, Charalampogiannis N, Fiedler M, Wakileh G, Gozen A, Rassweiler J. Analysis of performance factors in 240 consecutive cases of robot-assisted flexible ureteroscopic stone treatment. J Robot Surg. 2021 Apr;15(2):265-274. doi: 10.1007/s11701-020-01103-5. Epub 2020 Jun 16.

    PMID: 32557097BACKGROUND

  • Tae BS, Balpukov U, Cho SY, Jeong CW. Eleven-year Cumulative Incidence and Estimated Lifetime Prevalence of Urolithiasis in Korea: a National Health Insurance Service-National Sample Cohort Based Study. J Korean Med Sci. 2018 Jan 8;33(2):e13. doi: 10.3346/jkms.2018.33.e13.

    PMID: 29215822BACKGROUND

  • Sorokin I, Mamoulakis C, Miyazawa K, Rodgers A, Talati J, Lotan Y. Epidemiology of stone disease across the world. World J Urol. 2017 Sep;35(9):1301-1320. doi: 10.1007/s00345-017-2008-6. Epub 2017 Feb 17.

    PMID: 28213860BACKGROUND

  • Geraghty R, Abourmarzouk O, Rai B, Biyani CS, Rukin NJ, Somani BK. Evidence for Ureterorenoscopy and Laser Fragmentation (URSL) for Large Renal Stones in the Modern Era. Curr Urol Rep. 2015 Aug;16(8):54. doi: 10.1007/s11934-015-0529-3.

    PMID: 26077357BACKGROUND

  • Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.

    PMID: 27238616BACKGROUND

  • Park IW, Kim SJ, Shin D, Shim SR, Chang HK, Kim CH. Radiation exposure to the urology surgeon during retrograde intrarenal surgery. PLoS One. 2021 Mar 15;16(3):e0247833. doi: 10.1371/journal.pone.0247833. eCollection 2021.

    PMID: 33720938BACKGROUND

  • Mansoor SN, Al Arabia DH, Rathore FA. Ergonomics and musculoskeletal disorders among health care professionals: Prevention is better than cure. J Pak Med Assoc. 2022 Jun;72(6):1243-1245. doi: 10.47391/JPMA.22-76.

    PMID: 35751350BACKGROUND

  • Allaire PE, Kim HC, Maslen EH, Olsen DB, Bearnson GB. Prototype continuous flow ventricular assist device supported on magnetic bearings. Artif Organs. 1996 Jun;20(6):582-90.

    PMID: 8817961BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Study Officials

  • Chi Fai NG, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffi Kar Kei YUEN, FRCS-Surgery

CONTACT

35052625steffiyuen@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 28, 2024

Study Start

December 1, 2024

Primary Completion

December 31, 2025

Study Completion

March 3, 2026

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)