Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG Laser in Retrograde Intrarenal Surgery for Up… (NCT07012941) | Clinical Trial Compass
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Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureteral and Renal Stones
China448 participantsStarted 2025-07-01
Plain-language 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 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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;
What they're measuring
1
Stone-Free Rate at 4 Weeks Postoperative (Percentage of Participants)
Timeframe: 4 week post-operative
Trial details
NCT IDNCT07012941
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
✕. 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;