MOSES Laser System for Kidney Stones

Overseen By Brenda Romeo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albany Medical College

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Infection, Cancer, Neurogenic bladder, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser system, the MOSES laser system, for treating kidney stones. Researchers aim to determine how different laser techniques affect the time and energy required to break down kidney stones. The study involves three methods: dusting, fragmentation, and a hybrid approach. It seeks patients with large, dense kidney stones (10-20 mm in size). Those dealing with these troublesome stones might be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to explore innovative treatment options for kidney stones.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on mandatory anticoagulation therapies (blood thinners) and cannot stop them for surgery, you cannot participate.

What prior data suggests that the MOSES laser system is safe for treating kidney stones?

Research has shown that the MOSES laser system is safe for treating kidney stones. Studies indicate it works as effectively and safely as other laser treatments, with no significant difference in complication rates between the MOSES system and regular lasers.

The MOSES laser also reduces retropulsion, which occurs when stones move during treatment, decreasing the likelihood of stones shifting and causing issues. Overall, safety data demonstrates that patients tolerate the MOSES laser well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MOSES Laser System for kidney stones because it offers a new approach to breaking down stones with precision. Unlike traditional methods like extracorporeal shock wave lithotripsy (ESWL) or standard laser lithotripsy, the MOSES system provides flexible ureteroscopy with three different techniques: Dusting, Fragmentation, and Hybrid. This system's unique laser parameters allow for more efficient energy delivery, potentially reducing treatment time and minimizing damage to surrounding tissues. The Dusting technique uses low energy and high frequency for gradual stone reduction, while Fragmentation uses higher energy for breaking stones into larger pieces. The Hybrid method combines both, offering versatility depending on the stone's characteristics. These innovative techniques could lead to quicker recovery times and improved patient outcomes.

What evidence suggests that the MOSES laser system is effective for treating kidney stones?

Research has shown that the MOSES laser system effectively treats kidney stones. In this trial, participants will undergo flexible ureteroscopy using various lasing techniques with the MOSES laser system. Studies have found that this laser speeds up procedures compared to standard methods, breaking down stones more quickly. The MOSES laser also leaves fewer stone fragments, resulting in higher rates of being stone-free. It is considered safe and efficient for treating urinary stones. Overall, the MOSES laser presents a promising option for those dealing with kidney stones. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with large kidney stones (10-20 mm in total diameter) and a stone density of at least 1000 Hounsfield units. Suitable candidates can undergo flexible ureteroscopy. Pregnant individuals, those currently battling infections or cancer, patients with spinal cord injuries, neurogenic bladder, abnormal kidney anatomy, history of certain urinary tract procedures or strictures, prior abdominal/pelvic radiotherapy, or on non-stop anticoagulants are excluded.

Inclusion Criteria

The doctor decides if you can have a flexible ureteroscopy.

I have large kidney stones measuring in total 10-20 mm.

Your kidney stone is very dense, with a score of at least 1000 on a special type of X-ray.

Exclusion Criteria

I have had surgery on the same side as my kidney stones before.

You have had problems with your bladder related to nerve issues in the past.

You have a history of narrowings in the tube that carries urine from one of your kidneys to your bladder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo flexible ureteroscopy with different lasing techniques (dusting, fragmentation, hybrid) to evaluate total lasing time and energy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ureteroscopy procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MOSES laser system

Trial Overview The study tests the MOSES laser system's effectiveness in reducing lasing time and energy during ureteroscopic removal of large dense kidney stones using different techniques: dusting them into fine particles, breaking them into fragments or combining both methods.

How Is the Trial Designed?

Group I: Flexible Ureteroscopy with Hybrid Experimental Treatment 1 Intervention

Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters.

Group II: Flexible Ureteroscopy with Fragmentation Experimental Treatment 1 Intervention

Flexible ureteroscopy utilizing the Fragmentation lasing technique. MOSES parameters will be set to 0.8-1 JULES and a frequency of 8-10 hertz

Group III: Flexible Ureteroscopy with Dusting Experimental Treatment 1 Intervention

Flexible ureteroscopy with the dusting lasing technique. MOSES parameters will be set to an energy of 0.3-0.4 Jules and a frequency of 50-80 hertz

MOSES laser system is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as MOSES laser system for:

• Kidney stones
• Ureteral stones
• Bladder stones

Approved in European Union as MOSES laser system for:

• Kidney stones
• Ureteral stones
• Bladder stones

Approved in Canada as MOSES laser system for:

• Kidney stones
• Ureteral stones
• Bladder stones

Approved in Japan as MOSES laser system for:

• Kidney stones
• Ureteral stones
• Bladder stones

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+

Published Research Related to This Trial

Moses technology, using a Holmium:YAG laser, shows improved stone ablation efficiency, especially for soft stones, when the laser is in direct contact or just 1mm away from the stone surface.

The study found that while contact with the stone yields the best results, Moses technology at a distance of 1mm outperforms other pulse settings, indicating its potential for effective stone treatment with minimal fiber degradation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dusting Efficiency of the Moses Holmium Laser: An Automated In Vitro Assessment. Winship, B., Wollin, D., Carlos, E., et al.[2019]

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]

Moses technology significantly improves laser lithotripsy efficiency, achieving 160% higher stone ablation volume compared to the Regular mode, as demonstrated in both in vitro and in vivo studies.

The Moses mode also reduces stone retropulsion by 50 times during laser treatment, leading to less damage to surrounding tissues and potentially shorter procedural times, enhancing the safety of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Moses Technology to Improve Holmium Laser Lithotripsy Outcomes: A Preclinical Study. Elhilali, MM., Badaan, S., Ibrahim, A., et al.[2019]

In a study of 176 ureteroscopy cases, the use of Moses technology with the Lumenis Pulse P120H holmium laser did not significantly improve procedural efficiency compared to the regular mode, as measured by procedural time, fragmentation time, and energy used.

There were no significant differences in complication rates or stone-free rates between the Moses and regular modes, suggesting that while Moses technology may have potential benefits, they were not evident in this analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Impact of the Institution of Moses Technology on Efficiency During Retrograde Ureteroscopy for Stone Disease: Single-Center Experience. Knoedler, MA., Li, S., Best, SL., et al.[2022]

The Moses technology, used with a holmium laser during mini-percutaneous nephrolithotomy (PCNL), effectively reduces stone retropulsion and allows for efficient dusting and extraction of lower pole kidney stones, as demonstrated in a case involving a 63-year-old patient with a 1.5 cm stone.

The procedure resulted in complete stone removal without any adverse events, suggesting that mini-PCNL with Moses technology is a safe and effective alternative to traditional methods for treating lower pole stones, potentially allowing for outpatient treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory Tubeless Mini-Percutaneous Nephrolithotomy Using Moses Technology and Dusting Technique. Aldoukhi, AH., Black, KM., Shields, J., et al.[2019]

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]

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]

Moses laser lithotripsy shows similar safety and efficacy outcomes compared to conventional holmium laser lithotripsy for treating upper urinary calculi, based on a systematic review of four studies involving 892 patients.

The Moses technology significantly reduces laser working time compared to conventional methods, suggesting a potential efficiency advantage, although further research is needed to justify its higher operating costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Moses technology enhance the efficiency and outcomes of regular holmium laser lithotripsy? Results of a pooled analysis of comparative studies. Li, J., Huang, Y., Zhu, M., et al.[2023]

Citations

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

Does Moses technology improve the efficiency and outcomes ... While perioperative outcomes were equivalent between Moses and standard HLL, Moses was associated with faster lasing time and stone ablation speeds at the ...

2. 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.

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

Comparative effectiveness of high-power holmium laser ... MOSES technology purportedly allows for more effective stone dusting, which should translate into fewer residual stone fragments.

4. 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 ...

5. auajournals.org auajournals.org/doi/10.1097/01.JU.0001109944.05171.19.15

IP13-15 HOLMIUM MOSES LASER VERSUS THULIUM ... CONCLUSIONS: The MOSESTM and TFL laser systems demonstrate comparable efficacy for lithotripsy of renal calculi during f-URS, with neither ...

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. bostonscientific.com bostonscientific.com/en-US/products/lithotripsy/Lumenis-PulseTM-120H.html

Lumenis Pulse™ 120H - Holmium Laser Lithotripsy MOSES Technology displayed 50% reduction in retropulsion compared to standard Holmium pulse, potentially minimizing incidents of ureteral stone migration into ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2214388224000195

Review Flexible ureteroscopic treatment of kidney stones The photo-thermal mechanism of the holmium laser ensures safety during lithotripsy by minimizing urinary calculus migration, known as stone retropulsion, while ...

9. withpower.com withpower.com/trial/phase-kidney-calculi-7-2022-d1417

TFL vs MOSES Laser for Kidney Stones The safety data for TFL and MOSES laser treatments for kidney stones indicate that both technologies have comparable efficacy and safety profiles.

10. link.springer.com link.springer.com/article/10.1007/s00240-025-01720-5

Prospective evaluation of efficacy, safety, cumulative laser ... Overall, the SOLTIVE™ SuperPulsed Laser TFL System is a safe and effective in laser lithotripsy with low complication and re-intervention rates.