Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones
Completed · Not applicable
Conditions studied: Renal Stone
In brief
This is a prospective randomized controlled trial designed to assess the efficacy and safety of Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser (thulium fiber laser), in dusting of renal stones during ureteroscopy with laser lithotripsy. 310 participants will be enrolled across 5 research sites.
Key facts
- Study ID
- NCT06070714
- Run by
- University of Wisconsin, Madison
- People needed
- 178
- Starts
- 2023-09-07
- Expected to finish
- 2025-10-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with renal stones who require endoscopic laser treatment in the outpatient operating room. Patients may have an ureteropelvic junction (UPJ) stone if the treatment of the stone is completed in the kidney.
- Patients' stone size in a single renal unit of greater than or equal to 5 millimeters (mm) and less than or equal to 20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT as assessed by the urologist. Patients with multiple stones will be included as long as their largest stone size falls within the above parameters.
You may not qualify if…
- Pregnant patients
- Patients with transplant kidneys or other anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture
- Patients with irreversible coagulopathy
- Patients with known ureteral stricture disease
- Patient who do not have a pre-operative CT
- Non-English speaking patients and patients in other vulnerable groups such as lacking of decision-making capability, prisoner, or adult unable to consent
- Uric acid composition greater than 50 percent on pre operative stone analysis. Patients will be excluded post operatively if stone analysis from the time of surgery is greater than 50 percent uric acid.
- Prior ureteroscopy within 6 weeks of current surgery
- Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope
- Patients with only ureteral stones (ureteropelvic junction stones may be included as long as treated in the kidney)
- Patients with renal tubular acidosis or medullary sponge kidney
Where it is running
- University of California - Los Angeles — Los Angeles, California, United States
- Mount Sinai Health System — New York, New York, United States
- Glickman Urological & Kidney Institute — Cleveland, Ohio, United States
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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