AzTrials
AzTrials

UreterolithiasisNCT07012941

Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureteral and Renal Stones

A study testing Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone and Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone in people with Ureterolithiasis and Renal Calculi, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The holmium laser is currently considered the gold standard for lithotripsy on urinary lithiasis, whereas the super-pulsed thulium fibre laser is a relatively new technology. Through a multi-center prospective randomised clinical study that mainly aims to explore the effectiveness and safety of a super-pulsed fibre… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ureterolithiasis, Renal Calculi
What is being tested?
Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone and Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
448 participants
Where
1 siteChina
Study dates
1 Jul 2025to 20 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 ≤ Age ≤ 75 years old, regardless of gender, able to tolerate surgery;
  • Patients who have been confirmed by bilateral renal/urinary tract CT to have upper ureteral or renal stones, single or multiple, and are planning to undergo ureteroscopic lithotripsy for stone removal;
  • Confirmed by bilateral renal/urinary tract CT, the cumulative maximum diameter of stones is 10mm<cumulative maximum diameter ≤ 25mm;
  • Those who voluntarily participate and sign an informed consent form.

Who cannot join

  • Uncontrollable systemic hemorrhagic disease;
  • Severe spinal deformities, severe hip joint deformities, and difficulty in lithotomy position;
  • Uncontrolled urinary tract infections;
  • Any intracavitary surgery caused by anatomical factors of the urinary system cannot be performed;
  • Pregnant, planned pregnancy within 3 months, and lactating female patients;
  • The patients determined by the investigator to be unsuitable for this study include (but are not limited to): known to have human immunodeficiency virus (HIV) or AIDS; Suffering from mental illness; Infectious diseases;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kewei Xu, MD, PhD contact

+86-13632331628

xukewei@mail.sysu.edu.cn

China1 site

  • Sun Yat sen Memorial Hospital of Sun Yat sen University

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: An Application of Super-pulsed TFL vs Ho:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureter and Renal Stones: A Multi-center Prospective Randomized Controlled Trial

The holmium laser is currently considered the gold standard for lithotripsy on urinary lithiasis, whereas the super-pulsed thulium fibre laser is a relatively new technology. Through a multi-center prospective randomised clinical study that mainly aims to explore the effectiveness and safety of a super-pulsed fibre thulium laser compared to a holmium laser in the treatment of upper ureteral and renal stones (10mm<cumulative maximum diameter ≤ 25mm) in retrograde intrarenal surgery. The research participants are assigned randomly to undergo retrograde intrarenal surgery (RIRS) either using a super-pulsed thulium fibre laser or a holmium-YAG laser with an allocation ratio of 1:1. The secondary aim of this study is to provide high-level evidence for the development of diagnostic and treatment guidelines in the field of urolithiasis, both domestically and internationally. The outcomes of the RIRS procedures are compared for the two treatment arms.

Read the detailed description

Endoscopic surgery is the predominant method for treating urinary tract stones. The field of surgery has progressed from traditional open procedures and percutaneous lithotripsy to more advanced techniques such as mini, micro, and ureteroscopy methods. RIRS, which stands for retrograde intrarenal surgery, is a therapeutic option for upper ureteric or renal stones that are less than 2cm. Although various energy systems have been employed for stone fragmentation during ureteroscopy, laser energy is the predominant method used for this purpose. Both domestic and foreign criteria recommend the holmium laser. The thermal effects of the Ho:YAG laser efficiently pulverise stones. As a result, it is currently the most widely used laser for conducting laser lithotripsy on stones in the urinary tract. Unfortunately, the holmium-YAG laser system has some intrinsic problems, such as different components having varying effects. 2. During the fragmentation process, the stone displacement is large and difficult to accurately control. 3. Some stones cannot be powdered, heat-damaged, or perforated. 4. Mucosal damage during fragmentation makes it easy to bleed and ooze. 5. The powdering efficiency is low, the fragmentation time is long, there is a lower energy conversion ratio, excessive heat generation in machines, noise, etc. Thus, clinical practice requires a new laser technology to overcome the holmium laser's limitations.

Thus, new laser systems are being created to fix the issue. The newest laser technology, super-pulsed thulium fiber laser (SPTFL), has promising results. A super-pulse fibre thulium laser is a pulsed fibre thulium laser that can be clinically used for lithotripsy. In 2005, in vitro experiments related to super-pulsed fibre thulium laser lithotripsy were first reported. Experimental data suggests that, compared with holmium laser, thulium laser has the following advantages in urinary tract stone lithotripsy: 1. TFL has higher lithotripsy efficiency, and the stone ablation speed is 1.5-4 times faster than that of Ho:YAG. 2. A safer lithotripsy with a 4-fold reduction in penetration depth and a limited temperature increase inside the cavity (up to 39 °C). 3. Lower costs: low maintenance costs, low fibre damage, low equipment volume (1/8), high energy conversion. Subsequently, an increasing number of in vitro experiments and clinical studies have been conducted internationally. However, there is a scarcity of studies in the literature that directly compare the effectiveness and stone free rates of the Holmium-YAG laser and SPTFL systems. Consequently, investigators are interested in conducting a formal multi-center prospective randomised clinical study to compare the two systems in RIRS.

Being tested
Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone, Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone
Keywords
Super pulse thulium fiber laser (SPTFL), Ho:YAG laser, Lithotripsy, Ureteral Stone, Ureteroscopy, renal stone
Medical subject headings
Ureterolithiasis, Kidney Calculi, Nephrolithiasis

What participants receive

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

  • Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stoneDevice

    RIRS procedure for upper ureteral or renal stone lithotripsy with Superpulsed Thulium Laser

  • Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stoneDevice

    RIRS procedure for upper ureteral or renal stone lithotripsy with Holmium: YAG Laser

Study groups in NCT07012941
Study groupRoleWhat they receive
Superpulse Thulium Fiber laser (SPTFL)Active comparatorWith the help of a Superpuled Thulium Fibre laser machine, the ureteral or renal stones that are going to be treated with the RIRS procedure are either fragmented or dusted as part of the procedure.
Receives: Device: Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone
Holmium: YAG laserActive comparatorWith the help of a Holmium fibre laser machine, the ureteral or renal stones that are going to be treated with the RIRS procedure are either fragmented or dusted as part of the procedure.
Receives: Device: Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone

What is being measured

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

  1. Stone-Free Rate at 4 Weeks Postoperative (Percentage of Participants)

    Urinary tract CT（Computed Tomography）scan at 4 weeks post-operative did not reveal residual stones or residual stones with a diameter ≤ 2 mm and no clinical symptoms were defined as stone clearance

    Measured: 4 week post-operative

Secondary outcomes (10)

  1. Intraoperative complication rate (Percentage of Participants)

    Includes ureteral or renal pelvis perforation, mucosal avulsion, ureteral rupture, conversion to other treatments, and success rate of ureteral access sheath insertion.

    Measured: During the procedure

  2. Change in Hemoglobin from Baseline (g/dL)

    Hemoglobin measured before and within 24 hours after surgery

    Measured: Within 24 hours postoperative

  3. Change in Serum Creatinine from Baseline (μmol/L)

    Serum creatinine measured before and within 24 hours after surgery

    Measured: Within 24 hours postoperative

  4. Change in Blood Urea Nitrogen from Baseline (mmol/L)

    BUN measured before and within 24 hours after surgery

    Measured: Within 24 hours postoperative

  5. Operative time (Minutes)

    Duration of operation

    Measured: Decided immediately after the surgery

  6. Lithotripsy time (Minutes)

    Time spent performing laser lithotripsy

    Measured: intra-operation

  7. Length of Hospital Stay (Days)

    Total number of days the participant is hospitalized for the surgical procedure, from the day of surgery until discharge

    Measured: up to 30 days

  8. Total hospitalization costs

    Total cost incurred during the participant's hospital stay for the surgical procedure, including all procedural and inpatient care charges

    Measured: Up to 3 months

  9. Postoperative Complications (Clavien-Dindo Classification, Percentage of Participants)

    Postoperative complications, Recording data according to the Clavien-Dindo classification such as infection, pain, ureteral stricture and other complications that result in the need for intervention or readmission or surgical revision following the RIRS procedure.

    Measured: Up to 30 days post-operative

  10. Number of Additional Staged Procedures (Count per Participant)

    Number of additional surgical procedures required due to incomplete stone clearance, based on imaging findings at the 4-week follow-up after the initial RIRS procedure

    Measured: Up to 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 posted10 Jun 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion20 Mar 2027 (estimated)

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
Model description
Arm 1: Superpulse Thulium Fiber laser Arm 2: Holmium:YAG laser
Masking
Single blind
Who is masked
Participant
Enrolment
448 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07012941
Sponsor's protocol ID
SYSKY-2024-050-01
Status last verified
Jun 2025
First submitted
20 May 2025
Last updated
10 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang W, Fan J, Huang G, Li J, Zhu X, Tian Y, Su L. Prevalence of kidney stones in mainland China: A systematic review. Sci Rep. 2017 Jan 31;7:41630. doi: 10.1038/srep41630.

    PubMed 28139722

  • Khan SR, Pearle MS, Robertson WG, Gambaro G, Canales BK, Doizi S, Traxer O, Tiselius HG. Kidney stones. Nat Rev Dis Primers. 2016 Feb 25;2:16008. doi: 10.1038/nrdp.2016.8.

    PubMed 27188687

  • Fried NM, Irby PB. Advances in laser technology and fibre-optic delivery systems in lithotripsy. Nat Rev Urol. 2018 Sep;15(9):563-573. doi: 10.1038/s41585-018-0035-8.

    PubMed 29884804

  • Teichmann HO, Herrmann TR, Bach T. Technical aspects of lasers in urology. World J Urol. 2007 Jun;25(3):221-5. doi: 10.1007/s00345-007-0184-5. Epub 2007 May 30.

    PubMed 17534625

  • Emiliani E, Kanashiro A, Angerri O. Lasers for stone lithotripsy: advantages/disadvantages of each laser source. Curr Opin Urol. 2023 Jul 1;33(4):302-307. doi: 10.1097/MOU.0000000000001092. Epub 2023 Mar 17.

    PubMed 36927702

  • 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

  • Hale GM, Querry MR. Optical Constants of Water in the 200-nm to 200-microm Wavelength Region. Appl Opt. 1973 Mar 1;12(3):555-63. doi: 10.1364/AO.12.000555.

    PubMed 20125343

  • Ventimiglia E, Doizi S, Kovalenko A, Andreeva V, Traxer O. Effect of temporal pulse shape on urinary stone phantom retropulsion rate and ablation efficiency using holmium:YAG and super-pulse thulium fibre lasers. BJU Int. 2020 Jul;126(1):159-167. doi: 10.1111/bju.15079. Epub 2020 May 18.

    PubMed 32277557

  • Solano C, Corrales M, Panthier F, Candela L, Doizi S, Traxer O. Navigating urolithiasis treatment: assessing the practicality and performance of thulium fiber laser, holmium YAG, and thulium YAG in real-world scenarios. World J Urol. 2023 Oct;41(10):2627-2636. doi: 10.1007/s00345-023-04487-9. Epub 2023 Jul 20.

    PubMed 37468656

  • Dorantes-Carrillo LA, Basulto-Martinez M, Suarez-Ibarrola R, Heinze A, Proietti S, Flores-Tapia JP, Esqueda-Mendoza A, Giusti G. Retrograde Intrarenal Surgery Versus Miniaturized Percutaneous Nephrolithotomy for Kidney Stones >1cm: A Systematic Review and Meta-analysis of Randomized Trials. Eur Urol Focus. 2022 Jan;8(1):259-270. doi: 10.1016/j.euf.2021.02.008. Epub 2021 Feb 21.

    PubMed 33627307

  • Jiao B, Luo Z, Xu X, Zhang M, Zhang G. Minimally invasive percutaneous nephrolithotomy versus retrograde intrarenal surgery in surgical management of upper urinary stones - A systematic review with meta-analysis. Int J Surg. 2019 Nov;71:1-11. doi: 10.1016/j.ijsu.2019.09.005. Epub 2019 Sep 12.

    PubMed 31521837

  • Li Z, Lai C, Shah AK, Xie W, Liu C, Huang L, Li K, Yu H, Xu K. Comparative analysis of retrograde intrarenal surgery and modified ultra-mini percutaneous nephrolithotomy in management of lower pole renal stones (1.5-3.5 cm). BMC Urol. 2020 Mar 16;20(1):27. doi: 10.1186/s12894-020-00586-6.

    PubMed 32178654

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone and Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone in people with Ureterolithiasis and Renal Calculi, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jun 2025. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Kewei Xu, MD, PhD (+86-13632331628, xukewei@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stone-Free Rate at 4 Weeks Postoperative (Percentage of Participants) (time frame: 4 week post-operative). 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 NCT07012941, which also lists 13 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 10 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in