Holmium vs Thulium Lasers for Kidney Stones

Recruiting at 5 trial locations

Overseen By Shuang Li

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnancy, Transplant kidneys, Coagulopathy, Ureteral stricture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Day of procedure

310 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Holmium Laser with Moses Technology for kidney stones?

Research shows that the Holmium Laser with Moses Technology can reduce the time needed for kidney stone procedures and improve stone-free rates shortly after treatment. It is comparable in effectiveness to the Thulium Fiber Laser, with both treatments showing similar success in breaking down kidney stones and achieving stone-free outcomes. ^{1 2 3 4 5}

Is the use of Holmium and Thulium lasers for kidney stones safe?

Both Holmium laser with MOSES technology and Thulium fiber laser have been studied for treating kidney stones, and they show similar safety profiles with no significant differences in complications reported. These lasers are generally considered safe for use in humans for this purpose. ^{1 3 4 5 6}

How does the Holmium Laser with Moses Technology compare to other treatments for kidney stones?

The Holmium Laser with Moses Technology is unique because it reduces the movement of kidney stones during treatment and shortens the procedure time, potentially saving costs. It is compared to the Thulium Fiber Laser, which is also effective but may have a shorter operative time. Both treatments are similar in terms of safety and effectiveness in breaking down stones. ^{1 2 4 5 7}

Research Team

Stephen Nakada, MD, FACS, FRCS

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for patients with kidney stones sized between 5mm and 20mm who need laser treatment. It's not for pregnant individuals, those with transplant kidneys or certain anatomical variations, irreversible coagulopathy, ureteral strictures, non-English speakers without decision-making capacity, recent prior treatments, urothelial tumors, or specific metabolic conditions.

Inclusion Criteria

I need outpatient laser treatment for my kidney stones.

I had a kidney stone at the UPJ but it has been treated.

My kidney stone is between 5mm and 20mm in size.

Exclusion Criteria

You have not had a CT scan before your surgery.

I have a known narrowing of my ureters.

Pregnant patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo ureteroscopy with laser lithotripsy using either the holmium laser with Moses technology or the thulium fiber laser

Day of procedure

1 visit (in-person)

Follow-up

Participants are monitored for stone-free rate and quality of life post-operatively

6-10 weeks

1 visit (in-person)

Treatment Details

Interventions

• Holmium Laser with Moses Technology
• SuperPulsed Laser System with Thulium Fiber Laser

Trial Overview The study compares two types of lasers in breaking down kidney stones during surgery: the Lumenis® Pulse™ P120H holmium laser system using Moses technology versus the Soltive™ SuperPulsed Laser System with thulium fiber laser. Participants are randomly assigned to one of these treatments at five different research sites.

Participant Groups

Group I: Holmium laser with pulse modulation Active Control 1 Intervention

Group II: Thulium fiber laser Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

In a study of 2,075 patients undergoing flexible ureteroscopy for renal stones, thulium fiber laser demonstrated a significantly higher stone-free rate (85%) compared to holmium:YAG laser with MOSES technology (56%).

The thulium fiber laser was associated with a higher incidence of sepsis (9 cases) compared to the holmium:YAG laser (none), indicating potential safety concerns with the thulium fiber laser despite its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between Holmium:YAG Laser with MOSES Technology vs Thulium Fiber Laser Lithotripsy in Retrograde Intrarenal Surgery for Kidney Stones in Adults: A Propensity Score-matched Analysis From the FLEXible Ureteroscopy Outcomes Registry. Castellani, D., Fong, KY., Lim, EJ., et al.[2023]

The Moses technology for holmium laser lithotripsy significantly reduces procedure time, with a projected decrease of about 35% compared to traditional methods, based on prior studies.

Despite the reduction in lasing time, the higher costs associated with the Moses system do not result in overall cost savings for patients, particularly for stones larger than 10 mm, where the price differential remains substantial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Moses holmium system - time is money. Stern, KL., Monga, M.[2019]

In a study of 111 patients undergoing flexible ureteroscopy for kidney stones, both the holmium MOSES laser and thulium fiber laser (TFL) showed similar efficacy in stone removal, with no significant differences in stone-free rates or complications.

However, for calcium phosphate stones, the MOSES laser demonstrated a significantly shorter lasing time compared to TFL, indicating a potential advantage in treating this specific type of stone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thulium Fiber Laser vs Pulse-Modulated Holmium MOSES Laser in Flexible Ureteroscopy for the Management of Kidney Stones: A Single-Center Retrospective Analysis. Nikoufar, P., Hodhod, A., Fathy, M., et al.[2023]

In a study involving 102 patients undergoing mini-percutaneous nephrolithotomy for kidney stones, both high-power holmium laser with MOSES technology (HPH-M) and thulium fiber laser (TFL) demonstrated similar stone-free rates (SFR) after 48 hours, with HPH-M achieving 78.43% and TFL 68.63%.

While both lasers were comparable in fragmentation efficiency and dusting of stone fragments, TFL produced a higher proportion of larger fragments (>3 mm) compared to HPH-M, indicating that while both methods are effective, HPH-M may be more efficient in minimizing larger residual stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Power Holmium with MOSES Technology or Thulium Fiber Laser in MiniPerc with Suction: A New Curiosity. Patil, A., Reddy, N., Shah, D., et al.[2022]

The MOSES technique for holmium laser in kidney stone surgery significantly reduces operative time compared to the regular mode, particularly in smaller studies and in Asian populations.

There is no significant difference in stone-free rates or complication rates between the MOSES and regular modes, suggesting that while MOSES is faster, it does not compromise safety or effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and safety of holmium laser with the Moses technology and regular mode for stone treatment: a systematic review and meta-analysis. Li, P., Ma, Y., Yuan, C., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison Between Holmium:YAG Laser with MOSES Technology vs Thulium Fiber Laser Lithotripsy in Retrograde Intrarenal Surgery for Kidney Stones in Adults: A Propensity Score-matched Analysis From the FLEXible Ureteroscopy Outcomes Registry. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

The Moses holmium system - time is money. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Thulium Fiber Laser vs Pulse-Modulated Holmium MOSES Laser in Flexible Ureteroscopy for the Management of Kidney Stones: A Single-Center Retrospective Analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

High-Power Holmium with MOSES Technology or Thulium Fiber Laser in MiniPerc with Suction: A New Curiosity. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and safety of holmium laser with the Moses technology and regular mode for stone treatment: a systematic review and meta-analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Ex Vivo Renal Stone Dusting: Impact of Laser Modality, Ureteral Access Sheath, and Suction on Total Stone Clearance. [2022]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Retrograde intrarenal surgery using a 1.94 m superpulsed thulium fiber laser]. [2021]