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AzTrials

Ureteric StoneNCT05218057

to Compare the Effectiveness of Thulium Fiber Laser and Holmium YAG Laser for Ureteroscopic Lithotripsy

A study testing Ureteroscopic lithotripsy in people with Ureteric Stone, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ureteric Stone
What is being tested?
Ureteroscopic lithotripsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteHong Kong
Study dates
1 May 2022to 30 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • North District Hospital

    Sheung Shui

Other trials in Hong Kong

About this study

Official title: TFL vs Ho:YAG - A Prospective Study to Compare the Effectiveness of Thulium Fiber Laser and Holmium YAG Laser for Ureteroscopic Lithotripsy

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

Read the detailed description

Having the advantages of being minimally invasive and simple, ureteroscopic lithotripsy is one of the treatment 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. Currently, Holmium-YAG laser is the main laser platform being used due to its preciseness and safety. Unfortunately, Holmium-YAG laser system has some intrinsic problems, such as lower energy conversion ratio, excessive heat generation in machines, noise etc. Therefore, newer laser systems are being developed to overcome the problem. Thulium-fiber Laser (TFL) is the latest available laser system in the market with promising results. The advantages of TFL included better energy conversion ratio, less heat energy generation, more portable size, allow the generation of higher laser frequency for better stone dusting etc. Therefore, its uses are increasing popular. However, there are not many studies comparing the efficacy and stone free results of the Holmium-YAG laser and TFL systems in the literature. Therefore, investigators would like to perform a formal study to compare the two systems.

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Conditions
Ureteric Stone
Being tested
Ureteroscopic lithotripsy
Medical subject headings
Ureterolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ureteroscopic lithotripsyProcedure or surgery

    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.

Study groups in NCT05218057
Study groupRoleWhat they receive
Thulium-fibre laser (TFL)Active comparatorThe 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).
Receives: Procedure: Ureteroscopic lithotripsy
Holmium: yttrium-aluminum-garnet (Ho: YAG)Active comparatorThe 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).
Receives: Procedure: Ureteroscopic lithotripsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The efficiency of stone ablation

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

    Measured: Intraoperation

Secondary outcomes (6)

  1. Operation time

    Duration of operation

    Measured: Intra-operation

  2. Laser time

    Duration of laser use

    Measured: Intra-operation

  3. Length of hospital stay

    Total number of days of hospitalization for the surgical procedure

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

  4. Number of patient with Complications after surgical procedure

    Complications of treatment using Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: 30 days post-operation

  5. Stone free rate

    Defined by no detectable stone on post-operative 3-month NCCT

    Measured: 3 months post-operation

  6. Number of patients require auxiliary procedure after the intervention

    Defined by any additional procedure

    Measured: 3 months post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start1 May 2022
  3. Primary completion29 Sep 2023
  4. Study completion30 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218057
Sponsor's protocol ID
CRE 2021.652
Status last verified
Jan 2024
First submitted
30 Dec 2021
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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

  • 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.

    PubMed 28868500

  • 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

  • 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.

    PubMed 23165399

  • 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.

    PubMed 30575154

  • 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.

    PubMed 29256629

  • 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.

    PubMed 30729311

  • 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.

    PubMed 30615704

  • 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.

    PubMed 31055626

  • 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.

    PubMed 33238763

  • 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.

    PubMed 34362169

Questions about this trial

What is this clinical trial studying?

A study testing Ureteroscopic lithotripsy in people with Ureteric Stone, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficiency of stone ablation (time frame: Intraoperation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05218057, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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