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

Trial Summary

What is the purpose of this trial?

This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.

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 data supports the effectiveness of the MOSES laser system treatment for kidney stones?

Research shows that the MOSES laser system can reduce stone movement and improve the breaking down of kidney stones, potentially making the procedure quicker and more efficient compared to traditional methods. ^{1 2 3 4 5}

Is the MOSES Laser System safe for treating kidney stones?

The MOSES Laser System, a type of holmium laser, has been studied for treating kidney stones and shows no significant difference in complication rates compared to regular holmium laser treatments. This suggests it is generally safe for use in humans. ^{1 2 3 6 7}

How is the MOSES laser system treatment for kidney stones different from other treatments?

The MOSES laser system is unique because it uses a special pulse technology that reduces stone movement during treatment, making it more efficient at breaking down kidney stones compared to regular laser methods. This can lead to shorter procedure times and potentially lower costs for patients. ^{1 2 4 5 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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, 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]

References

1. 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]

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

Dusting Efficiency of the Moses Holmium Laser: An Automated In Vitro Assessment. [2019]

3. England 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. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

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

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

Use of the Moses Technology to Improve Holmium Laser Lithotripsy Outcomes: A Preclinical Study. [2019]

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

Clinical Impact of the Institution of Moses Technology on Efficiency During Retrograde Ureteroscopy for Stone Disease: Single-Center Experience. [2022]

7. 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]

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

Ambulatory Tubeless Mini-Percutaneous Nephrolithotomy Using Moses Technology and Dusting Technique. [2019]