An interventional study of 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 Ureterolithiasis and Renal Calculi, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
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.
84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.
This study's planned enrollment of 448 is above the median of 101 across 66 interventional studies indexed under Ureterolithiasis.
Browse Ureterolithiasis studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
With 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.
Device: Superpulse Thulium Fiber laser (SPTFL) ureteroscopy for treatment of upper urinary tract stone or renal stone
With 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.
Device: Holmium: YAG laser ureteroscopy for treatment of upper urinary tract stone or renal stone
RIRS procedure for upper ureteral or renal stone lithotripsy with Superpulsed Thulium Laser
RIRS procedure for upper ureteral or renal stone lithotripsy with Holmium: YAG Laser
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
Time frame: 4 week post-operative
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.
Time frame: During the procedure
Change in Hemoglobin from Baseline (g/dL)
Hemoglobin measured before and within 24 hours after surgery
Time frame: Within 24 hours postoperative
Change in Serum Creatinine from Baseline (μmol/L)
Serum creatinine measured before and within 24 hours after surgery
Time frame: Within 24 hours postoperative
Change in Blood Urea Nitrogen from Baseline (mmol/L)
BUN measured before and within 24 hours after surgery
Time frame: Within 24 hours postoperative
Operative time (Minutes)
Duration of operation
Time frame: Decided immediately after the surgery
Lithotripsy time (Minutes)
Time spent performing laser lithotripsy
Time frame: intra-operation
Length of Hospital Stay (Days)
Total number of days the participant is hospitalized for the surgical procedure, from the day of surgery until discharge
Time frame: up to 30 days
Total hospitalization costs
Total cost incurred during the participant's hospital stay for the surgical procedure, including all procedural and inpatient care charges
Time frame: Up to 3 months
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.
Time frame: Up to 30 days post-operative
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
Time frame: Up to 3 months post-operation
Plan to share: No
Start is estimated for Jul 2025; primary completion for Feb 2027, 19 months later.
Of 36 non-industry interventional studies with no phase under Ureterolithiasis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 19 months is close to that.
Counting every sponsor, half of 38 studies reached it within 20 months; a quarter within 11 and three quarters within 30.
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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