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

NCT06070714 | Completed Results FDA Device

• 3 other identifiers: 2023-0932UrologyProtocol Version 5/21/24
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

• Stone Free Rate

  The primary objective of this study is to compare the stone free rate as determined by ultra-low dose limited renal CT at 2 months post operatively between the holmium laser with pulse modulation and the thulium fiber laser.

  Post-operative (up to 10 weeks)

Secondary Outcomes (6)

• Stone Treatment Time in Minutes

  day of procedure (up to 3 hours)

• Procedural Time

  day of procedure (up to 3 hours)

• Total Energy Used in Kilojoules

  day of procedure (up to 3 hours)

• Number of Participants With Complications

  day of procedure (up to 10 weeks)

• Participant Quality of Life as Measured by the WISQOL Short Form Score Pre-procedure Assessment

  before the procedure (up to 3 hours before procedures)

Study Arms (2)

Holmium laser with pulse modulation

ACTIVE COMPARATOR

Device: Holmium laser with pulse modulation

Thulium fiber laser

ACTIVE COMPARATOR

Device: Thulium fiber laser

Interventions

Holmium laser with pulse modulation DEVICE

The holmium laser with pulse modulation emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed.

Holmium laser with pulse modulation

Thulium fiber laser DEVICE

The thulium fiber laser has a different wavelength then the holmium laser with pulse modulation and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns.

Thulium fiber laser

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (4)

University of California - Los Angeles

Los Angeles, California, 90095, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

Glickman Urological & Kidney Institute

Cleveland, Ohio, 44125, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 57392, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Stephen Nakada
• Organization: University of Wisconsin

nakada@urology.wisc.edu

608.263.1359

Study Officials

• Stephen Nakada, MD, FACS, FRCS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A single urologist will evaluate all CT scans for residual stones and will be blinded to which laser was used during ureteroscopy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized (ratio 1:1) to be treated with either the holmium laser with pulse modulation or the thulium fiber laser. Each site will randomize their own participants. Block randomization in block sizes of 4 will be used to assign participants to each laser treatment group. If unable to use the specified laser for any reason, the participant will be considered a withdrawal

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: September 7, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)