Robotic Flexible Ureteroscopy Versus Standard Flexible Ureteroscopy for Renal Stones

NCT ID: NCT06660914

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-03-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Flexible Ureteroscopy

Intervention Type PROCEDURE

Ureteroscopic lithotripsy

Standard flexible ureteroscopy

Standard flexible ureterscopy

Group Type ACTIVE_COMPARATOR

Flexible Ureteroscopy

Intervention Type PROCEDURE

Ureteroscopic lithotripsy

Interventions

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Flexible Ureteroscopy

Ureteroscopic lithotripsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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NG Chi Fai

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chi Fai NG, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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North District Hospital

Sheung Shui, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Steffi Kar Kei YUEN, FRCS-Surgery

Role: CONTACT

Facility Contacts

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Chi Fai NG, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 37337653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21683380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27604670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38478076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32557097 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29215822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28213860 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26077357 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27238616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33720938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35751350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8817961 (View on PubMed)

Other Identifiers

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CRE-2024.217

Identifier Type: -

Identifier Source: org_study_id

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