NCT06070714

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

Multi-Center Randomized Clinical Trial Evaluating the Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Fiber Laser on Renal Stones

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Renal Stone

Interventions

Type	Name	Description
DEVICE	Holmium laser with pulse modulation	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.
DEVICE	Thulium fiber laser	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.

Timeline

• Start date: 2023-09-07
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2023-10-06
• Last updated: 2026-02-27
• Results posted: 2026-02-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study