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Search / Trial NCT06070714

Efficiency and Safety of Holmium Laser with Moses Technology Versus SuperPulsed Laser System with Thulium Fiber Laser on Renal Stones

Launched by UNIVERSITY OF WISCONSIN, MADISON · Oct 2, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

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 modulation) versus the Soltive™ SuperPulsed Laser System with the thulium fiber laser technology (thulium fiber laser).

The primary objective is to compare the stone free rate as determined by computed tomography (CT) scan at two months (6-10 weeks) post operatively. A single urologist will evaluate all CT scans for residual stones and will be blinded to which laser was used during ureteroscopy.
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Gender

ALL

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

About University Of Wisconsin, Madison

The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.

Locations

Los Angeles, California, United States

Los Angeles, California, United States

Columbus, Ohio, United States

New York, New York, United States

Cleveland, Ohio, United States

Madison, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Stephen Nakada, MD, FACS, FRCS

Principal Investigator

University of Wisconsin, Madison

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported