Status:
ACTIVE_NOT_RECRUITING
Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Renal Stone
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief 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 modulatio...
Detailed Description
This study will be a randomized clinical trial comparing ureteroscopy with laser lithotripsy with the Lumenis® Pulse™ P120H holmium laser system with the Moses technology (holmium laser with pulse mod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT06070714
Start Date
September 7 2023
End Date
October 31 2025
Last Update
October 24 2025
Active Locations (4)
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1
University of California - Los Angeles
Los Angeles, California, United States, 90095
2
Mount Sinai Health System
New York, New York, United States, 10029
3
Glickman Urological & Kidney Institute
Cleveland, Ohio, United States, 44125
4
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 57392