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

Last updated: January 13, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Enrolling

Phase

N/A

Condition

Kidney Stones

Treatment

Thulium fiber laser

Holmium laser with pulse modulation

Clinical Study ID

NCT06070714
2023-0932
Protocol Version 5/21/24
Urology
Protocol Version 8/14/23
  • Ages 18-89
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with renal stones who require endoscopic laser treatment in the outpatientoperating room. Patients may have an ureteropelvic junction (UPJ) stone if thetreatment of the stone is completed in the kidney.

  • Patients' stone size in a single renal unit of greater than or equal to 5millimeters (mm) and less than or equal to 20 mm. Stone size is defined as thelargest 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 sizefalls within the above parameters.

Exclusion

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 aslacking 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 ofsurgery 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 laserlithotripsy, and failure to reach the stone in the upper urinary tract with theureteroscope

  • Patients with only ureteral stones (ureteropelvic junction stones may be included aslong as treated in the kidney)

  • Patients with renal tubular acidosis or medullary sponge kidney

Study Design

Total Participants: 310
Treatment Group(s): 2
Primary Treatment: Thulium fiber laser
Phase:
Study Start date:
September 07, 2023
Estimated Completion Date:
August 31, 2025

Study 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 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.

The following information will be collected for research purposes as secondary outcomes: (1) stone treatment time (time from the start of lasing to the end of lasing; minutes); (2) total operative time (minutes); (3) lasing time (minutes, time the laser was in use, not including pedal pauses); (4) total energy used (kilojoules, kJ); (5) laser efficiency (mm per minute); (6) number of times the laser pedals are pressed (left, right, and total pedal presses); (7) laser fiber size; (8) stone analysis; (9) complications, and (10) patients' quality of life.

The results from the pre- and post-operative quality of life survey (WISQOL short form) will be obtained from the patient's medical record. A total of 3 clinic visits (i.e., the pre-operative visit and the stone surgery, one post-operative visit after 2 months of the surgery) will be needed for this study.

All visits are standard of care. Stone parameters (i.e. size, location, Hounsfield units, presence of hydronephrosis, stone volume, and composition), demographic information, co-morbidities, and post-operative parameters will be collected from the medical record in HealthLink.

The Thulium laser company is not involved in this research.

Connect with a study center

  • University of California

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California - Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • Mount Sinai Health System

    New York, New York 10029
    United States

    Site Not Available

  • Glickman Urological & Kidney Institute

    Cleveland, Ohio 44125
    United States

    Site Not Available

  • Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin 57392
    United States

    Site Not Available

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