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RecruitingNCT06660914Updated May 6, 2025

Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones

An interventional study of Flexible Ureteroscopy in Renal Stone, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Renal Stone
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In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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

  • Active comparator
    Standard flexible ureteroscopy

    Standard flexible ureterscopy

    Procedure: Flexible Ureteroscopy

Interventions

  • ProcedureFlexible Ureteroscopy

    Ureteroscopic lithotripsy

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What researchers measure

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

    Time frame: Month 1

Secondary outcomes

  1. Stone-free rate at 3 month

    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

    Time frame: Month 3

  2. Operative time

    the time from insertion of an endoscope into the urethra to the completion of stent placement

    Time frame: During operation

  3. Lasing Time

    The total lasing time in minutes during operation

    Time frame: During operation

  4. Total laser energy used

    Total laser energy used during operation

    Time frame: During operation

  5. Total radiation dose

    Total radiation dose during operation

    Time frame: During operation

  6. Total radiation time

    total radiation time in minutes during operation

    Time frame: during operation

  7. Length of hospital stay

    defined from the day of surgery to the day of discharge, counted in days.

    Time frame: On Discharge

  8. Postoperative pain

    By visual analogue scores from 0-10, the highest score the more pain.

    Time frame: Baseline, Week 1 and Week 12

  9. Surgeon radiation exposure

    By radiation dosimeter

    Time frame: During operation

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Study locations

1 of 1 sites recruiting
  • North District Hospital
    Sheung Shui, Hong Kong
    Recruiting
08

References and documents

Publications

  • 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. PubMed 37337653 ↗
  • 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. PubMed 21683380 ↗
  • 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. PubMed 27604670 ↗
  • 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. PubMed 38478076 ↗
  • 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. PubMed 32557097 ↗
  • 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. PubMed 29215822 ↗
  • 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. PubMed 28213860 ↗
  • 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. PubMed 26077357 ↗
  • 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. PubMed 27238616 ↗
  • 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. PubMed 33720938 ↗
  • 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. PubMed 35751350 ↗
  • 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. PubMed 8817961 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06660914
Lead sponsor
Chinese University of Hong Kong
Responsible party
NG Chi Fai (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Oct 28, 2024
Start date
Dec 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Mar 3, 2026 (estimated)
Last update
May 6, 2025

Study contacts

Steffi Kar Kei YUEN, FRCS-Surgery
Contact
steffiyuen@surgery.cuhk.edu.hk
35052625
Chi Fai NG, MD
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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