NCT05218057

Brief Summary

This prospective randomized clinical trial aimed to compare the difference in stone ablation rates of TFL and Ho:YAG laser in a clinical setting. Patients are randomized to receive URS with lithotripsy (URSL) either with TFL or Ho:YAG with an allocation ratio of 1:1. Primary outcome is the efficiency of stone ablation in terms of the stone ablation rate

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

December 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 1, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

December 30, 2021

Last Update Submit

January 3, 2024

Conditions

Ureteric Stone

Outcome Measures

Primary Outcomes (1)

  • The efficiency of stone ablation

    Measured by stone ablation rate(pre-operative stone volume/ laser time)

    Intraoperation

Secondary Outcomes (6)

  • Operation time

    Intra-operation

  • Laser time

    Intra-operation

  • Length of hospital stay

    The total number of days of hospitalization for this surgical procedure up to day 30 after the procedure

  • Number of patient with Complications after surgical procedure

    30 days post-operation

  • Stone free rate

    3 months post-operation

  • +1 more secondary outcomes

Study Arms (2)

Thulium-fibre laser (TFL)

ACTIVE COMPARATOR

The laser used in this group for surgical procedure ureteroscopic lithotripsy will be the Olympus SOLTIVETM Premium SuperPulsed laser system with a 365micron laser fibre. The laser pulse setting will be 1J x 10Hz, short pulse duration (adjusted up to 600microseconds).

Procedure: Ureteroscopic lithotripsy

Holmium: yttrium-aluminum-garnet (Ho: YAG)

ACTIVE COMPARATOR

The laser used in this group for surgical procedure ureteroscopic lithotripsy will be the Lumenis VersaPulse® PowerSuiteTM 100W laser system with a 365micron laser fibre. The laser pulse setting will be 1J x 10Hz. Pulse duration is not adjustable in this machine (up to 600microseconds).

Procedure: Ureteroscopic lithotripsy

Interventions

Ureteroscopic lithotripsyPROCEDURE

Ureteroscopic lithotripsy is one of the surgical procedure options for ureteric stone less than 1.5 cm. While many energy systems has been used for stone fragmentation during ureteroscopy, laser energy is the most commonly used approach for stone fragmentation.

Holmium: yttrium-aluminum-garnet (Ho: YAG)Thulium-fibre laser (TFL)

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18-years-old with informed consent

You may not qualify if:

  • Patients on anti-coagulation
  • Patients with condition that increases the risk of urolithiasis (e.g. cystinuria, hyperparathyroidism, previous intestinal resection)
  • Patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture)
  • Patients with stones \> 15 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North District Hospital

Sheung Shui, Hong Kong

Location

Related Publications (11)

  • 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

  • Ziemba JB, Matlaga BR. Epidemiology and economics of nephrolithiasis. Investig Clin Urol. 2017 Sep;58(5):299-306. doi: 10.4111/icu.2017.58.5.299. Epub 2017 Aug 10.

    PMID: 28868500BACKGROUND

  • 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

  • Elashry OM, Tawfik AM. Preventing stone retropulsion during intracorporeal lithotripsy. Nat Rev Urol. 2012 Dec;9(12):691-8. doi: 10.1038/nrurol.2012.204. Epub 2012 Nov 20.

    PMID: 23165399BACKGROUND

  • Li JK, Teoh JY, Ng CF. Updates in endourological management of urolithiasis. Int J Urol. 2019 Feb;26(2):172-183. doi: 10.1111/iju.13885. Epub 2018 Dec 21.

    PMID: 30575154BACKGROUND

  • Saussine C, Andonian S, Pacik D, Popiolek M, Celia A, Buchholz N, Sountoulides P, Petrut B, de la Rosette JJMCH. Worldwide Use of Antiretropulsive Techniques: Observations from the Clinical Research Office of the Endourological Society Ureteroscopy Global Study. J Endourol. 2018 Apr;32(4):297-303. doi: 10.1089/end.2017.0629. Epub 2018 Jan 17.

    PMID: 29256629BACKGROUND

  • Traxer O, Keller EX. Thulium fiber laser: the new player for kidney stone treatment? A comparison with Holmium:YAG laser. World J Urol. 2020 Aug;38(8):1883-1894. doi: 10.1007/s00345-019-02654-5. Epub 2019 Feb 6.

    PMID: 30729311BACKGROUND

  • Fried NM. Recent advances in infrared laser lithotripsy [Invited]. Biomed Opt Express. 2018 Aug 30;9(9):4552-4568. doi: 10.1364/BOE.9.004552. eCollection 2018 Sep 1.

    PMID: 30615704BACKGROUND

  • Andreeva V, Vinarov A, Yaroslavsky I, Kovalenko A, Vybornov A, Rapoport L, Enikeev D, Sorokin N, Dymov A, Tsarichenko D, Glybochko P, Fried N, Traxer O, Altshuler G, Gapontsev V. Preclinical comparison of superpulse thulium fiber laser and a holmium:YAG laser for lithotripsy. World J Urol. 2020 Feb;38(2):497-503. doi: 10.1007/s00345-019-02785-9. Epub 2019 May 4.

    PMID: 31055626BACKGROUND

  • Martov AG, Ergakov DV, Guseynov M, Andronov AS, Plekhanova OA. Clinical Comparison of Super Pulse Thulium Fiber Laser and High-Power Holmium Laser for Ureteral Stone Management. J Endourol. 2021 Jun;35(6):795-800. doi: 10.1089/end.2020.0581. Epub 2021 Jan 13.

    PMID: 33238763BACKGROUND

  • Traxer O, Corrales M. Managing Urolithiasis with Thulium Fiber Laser: Updated Real-Life Results-A Systematic Review. J Clin Med. 2021 Jul 30;10(15):3390. doi: 10.3390/jcm10153390.

    PMID: 34362169BACKGROUND

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The urologist performing the surgery could not be blinded due to the nature of the intervention. Patients receiving the treatment and investigators assessing for the outcomes are blinded from the allocated treatment arm.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 30, 2021

First Posted

February 1, 2022

Study Start

May 1, 2022

Primary Completion

September 29, 2023

Study Completion

October 30, 2023

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

HK(1)