N/A
N=178
Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones
Renal Stone
Bottom Line
View on ClinicalTrials.gov: NCT06070714 ↗Enrolled (actual)
178
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Stone Free Rate — 36; 34 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Holmium laser with pulse modulation (Device); Thulium fiber laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Oct 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stone Free Rate |
36; 34 | — |
| SECONDARY Stone Treatment Time in Minutes |
15.7; 12.7 | — |
| SECONDARY Procedural Time |
43.6; 40 | — |
| SECONDARY Total Energy Used in Kilojoules |
5.6; 5.1 | — |
| SECONDARY Number of Participants With Complications |
7; 4 | — |
| SECONDARY Participant Quality of Life as Measured by the WISQOL Short Form Score Pre-procedure Assessment |
73.1; 70 | — |
| SECONDARY Participant Quality of Life as Measured by the WISQOL Short Form Score Post-procedure Assessment |
93; 88.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06070714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.