Holmium vs Thulium Lasers for Kidney Stones

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of laser treatments—holmium and thulium—for breaking down kidney stones during ureteroscopy. Researchers aim to determine which laser is more effective and safer for "dusting" or breaking the stones into tiny particles. Ideal participants have kidney stones between 5 mm and 20 mm in size that require laser treatment. As an unphased trial, this study allows participants to contribute to research that could enhance future kidney stone treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the holmium laser with Moses technology and the thulium fiber laser safely treat kidney stones. Studies indicate that the holmium laser works effectively with a small risk of complications. The procedure is quick, and many patients become stone-free afterward.

Similarly, the thulium fiber laser is safe and effective. Reports show high rates of patients being stone-free and low risks of side effects. A meta-analysis, which combines results from several studies, confirmed it as a good option for treating kidney and ureteral stones, with few problems after the procedure.

In summary, past research has demonstrated that both laser systems are safe, with few reported issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of lasers for treating kidney stones because these technologies offer promising advancements over current methods. The Holmium laser with Moses Technology is unique because it enhances energy delivery, making stone fragmentation more efficient and potentially reducing procedure time. Meanwhile, the Thulium Fiber Laser stands out for its ability to produce a continuous and adjustable laser beam, which can result in smoother stone removal and possibly less damage to surrounding tissues. These innovative laser techniques could offer more effective, quicker, and safer alternatives to traditional treatment options like extracorporeal shock wave lithotripsy or standard Holmium laser procedures.

What evidence suggests that this trial's laser treatments could be effective for kidney stones?

This trial will compare the effectiveness of two laser technologies for treating kidney stones. Research has shown that the Holmium laser with Moses technology, which participants in this trial may receive, effectively treats kidney stones. Studies indicate it breaks down stones well, resulting in high rates of patients being stone-free. It also carries a low risk of complications and can shorten procedure time. Meanwhile, the SuperPulsed Laser System with Thulium Fiber Laser, another treatment option in this trial, is also effective. It excels at turning stones into very fine dust, aiding in easier clearance. Both lasers are considered safe and efficient options for treating kidney stones. ^{2 4 6 7 8}

Who Is on the Research Team?

Stephen Nakada, MD, FACS, FRCS

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Thulium fiber laser Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9903166/

Does Moses technology improve the efficiency and outcomes ...

Retrograde ureteroscopy with holmium laser lithotripsy (HLL) is a standard treatment for urolithiasis. Moses technology has been shown to improve fragmentation ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11334128/

Outcomes of ureteroscopy and laser fragmentation using a ...

This study demonstrated that the 60 W MOSES laser was safe and efficient for the treatment of urinary stones with high stone-free rates and a small risk of ...

3.

bmcurol.biomedcentral.com

bmcurol.biomedcentral.com/articles/10.1186/s12894-023-01264-z

Comparison of the efficacy and safety of holmium laser with ...

MOSES mode holmium laser was superior to the regular mode laser in terms of procedure time. There was no large disparity in stone-free rates or complications.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1477513122002224

Comparative effectiveness of high-power holmium laser ...

Our results show that stone clearance is similar between the 120 W MOSES and 30 W Ho:YAG lasers. However, there are indications that high-power laser ...

5.

liebertpub.com

liebertpub.com/doi/10.1089/end.2021.0592

The Efficiency of Moses Technology Holmium Laser for ...

Results: Twenty-nine patients met the inclusion criteria. Mean (range) stone volume and density were 290 mm3 (42–1700) and 814 HU (170–1675), respectively.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10230678/

Comparison of the efficacy and safety of holmium laser with ...

MOSES mode holmium laser was superior to the regular mode laser in terms of procedure time. There was no large disparity in stone-free rates or complications.

7.

ucla.clinicaltrials.researcherprofiles.org

ucla.clinicaltrials.researcherprofiles.org/trial/NCT06070714

UCLA Kidney Stones Trial → Efficiency and Safety of Holmium ...

This is a prospective randomized controlled trial designed to assess the efficacy and safety of Lumenis® Pulse™ P120H holmium laser system with the Moses ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04505956

NCT04505956 | A Comparison of Ureteroscopic Treatment ...

Initial preclinical studies demonstrated significantly reduced stone retropulsion and higher stone ablation volume with Moses technology, leading to the ...