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NCT Number: NCT07012941

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat sen Memorial Hospital of Sun Yat sen University

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

Treatment and study plan

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

Device

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 stone

Device

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

Primary outcomes

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

    Time frame: 4 week post-operative

    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

Secondary outcomes

  1. Intraoperative complication rate (Percentage of Participants)

    Time frame: During the procedure

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

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

    Time frame: Within 24 hours postoperative

    Hemoglobin measured before and within 24 hours after surgery

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

    Time frame: Within 24 hours postoperative

    Serum creatinine measured before and within 24 hours after surgery

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

    Time frame: Within 24 hours postoperative

    BUN measured before and within 24 hours after surgery

  5. Operative time (Minutes)

    Time frame: Decided immediately after the surgery

    Duration of operation

  6. Lithotripsy time (Minutes)

    Time frame: intra-operation

    Time spent performing laser lithotripsy

  7. Length of Hospital Stay (Days)

    Time frame: up to 30 days

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

  8. Total hospitalization costs

    Time frame: Up to 3 months

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

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

    Time frame: Up to 30 days post-operative

    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.

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

    Time frame: Up to 3 months post-operation

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kewei Xu, MD, PhD

CONTACT

[email protected]

+86-13632331628

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Collaborators

  • Beijing Friendship Hospital
  • Beijing Tsinghua Changgeng Hospital
  • Peking University Shenzhen Hospital
  • People's Hospital of Guangxi Zhuang Autonomous Region
  • RenJi Hospital
  • Renmin Hospital of Wuhan University
  • Second Affiliated Hospital of Guangzhou Medical University
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shenzhen People's Hospital
  • Tongji Hospital
  • West China Hospital

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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