Laser Lithotripsy for Kidney Stones

Overseen By Allaa Fadl-Alla, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Staged surgery, Nephrocalcinosis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Day of procedure

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of laser technology for breaking down kidney stones into tiny fragments. The researchers aim to determine if the newer Moses 2.0 technology with pulse modulation is more efficient than standard high-powered laser technology. The goal is to identify which method reduces surgery time and improves outcomes. The trial seeks participants undergoing treatment for kidney or ureteral stones between 8 mm and 20 mm in size. As an unphased trial, it offers participants the chance to contribute to advancing medical knowledge and potentially benefit from cutting-edge technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this laser technology is safe for kidney stone treatment?

Research shows that the Moses 2.0 laser, already approved by the FDA, is generally well-received in medical use. Studies have found that it breaks kidney stones faster and more efficiently than standard laser methods.

No major safety issues have been reported with this technology. Patients treated with the Moses 2.0 laser have not experienced more side effects than those treated with the standard high-powered laser. This suggests both treatments are equally safe for people with kidney stones. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about laser lithotripsy for kidney stones because it uses advanced laser technology to break down stones more efficiently. Unlike traditional methods, which may involve surgery or less precise laser techniques, this approach utilizes a high-powered holmium laser with specific settings for "dusting" stones into tiny fragments. There are two variations being tested: one uses the standard high-powered laser, and the other incorporates Moses 2.0 pulse modulation, which may enhance precision and reduce treatment time. These innovations could lead to quicker recoveries and fewer complications for patients suffering from kidney stones.

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

This trial will compare two different laser technologies for kidney stone treatment. Research has shown that Moses 2.0 laser technology, which participants in one arm of this trial may receive, makes breaking down kidney stones more efficient. Specifically, one study found that it works faster, breaking up stones more quickly. This technology also speeds up stone removal, making the entire procedure quicker. Compared to the standard holmium laser, used in another arm of this trial, Moses 2.0 is more efficient in both breaking up and removing stones. These improvements suggest that Moses 2.0 may provide better results for patients with kidney stones. ^{2 4 6 7 8}

Who Is on the Research Team?

Amy Krambeck, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals with kidney or ureteral stones measuring between 6mm and less than 20mm, who are undergoing a procedure called ureteroscopy. The study aims to include those who require stone removal using laser technology.

Inclusion Criteria

Willing to sign informed consent

I am scheduled for a procedure to remove kidney stones using a scope and laser.

I have kidney or ureter stones between 8 and 20 mm, with up to 4 stones.

Exclusion Criteria

I am under 18 years old.

Inability to provide informed consent

Members of vulnerable patient populations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopy with high-powered holmium laser lithotripsy, with or without Moses 2.0 pulse modulation, to treat kidney and ureteral stones.

Day of procedure

1 visit (in-person)

Follow-up

Participants are monitored for stone-free status and potential postoperative complications using renal bladder ultrasound and KUB X-ray.

8-12 weeks

1-2 visits (in-person)

Additional Follow-up

If abnormal findings are detected, participants may undergo repeat imaging to check for postoperative conditions.

1 month after initial follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Dusting

Trial Overview The study compares two methods of breaking down kidney stones: the Moses 2.0 pulse modulation technology versus the standard high-powered Holmium Laser without this feature. It will assess which method is more efficient in terms of operating time, laser usage, energy required, and success in eliminating stones.

How Is the Trial Designed?

Group I: Standard High-powered arm Active Control 1 Intervention

Ureteroscopy with high powered holmium laser lithotripsy without Moses 2.0 pulse modulation. Ureteral dusting settings: 0.2-0.3 x 60 Hz (not to exceed 20 W) Renal dusting settings: 0.2-0.5 J x 80 Hz standard (not to exceed 40 W)

Group II: Moses 2.0 arm Active Control 2 Interventions

Ureteroscopy with high powered holmium laser lithotripsy with Moses 2.0 pulse modulation. Ureteral dusting settings: 0.2-0.3x60 Hz (not to exceed 20 W) Renal dusting settings: 0.2-0.3 J x 120 Hz (not to exceed 40 W)

Dusting is already approved in United States, European Union for the following indications:

Approved in United States as Moses 2.0 for:

• Kidney stones
• Ureteral stones

Approved in European Union as Moses 2.0 for:

• Kidney stones
• Ureteral stones
• Benign prostate hyperplasia (BPH)

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Ureteroscopic laser lithotripsy using the Holmium:YAG laser can be performed using two main techniques: 'dusting' (low energy, high frequency) and 'fragmentation with extraction' (high energy, low frequency), both of which are effective for treating urinary stones.

While dusting is associated with shorter procedure times and less risk of ureteral damage, it may increase the risk of future stone formation if debris is not fully cleared; fragmentation with extraction allows for more complete stone removal but may take longer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ureteroscopic Laser Lithotripsy: A Review of Dusting vs Fragmentation with Extraction. Matlaga, BR., Chew, B., Eisner, B., et al.[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]

Holmium:YAG lithotripsy is effective for breaking down all types of kidney stones, showing high success rates in treatment.

Using angled optical fibers and higher power settings can enhance the speed of the lithotripsy process, making it particularly effective for larger renal and bladder stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium:YAG lithotripsy for large renal and bladder calculi: strategies for efficient lithotripsy. Teichman, JM.[2016]

In a study of 131 pediatric patients undergoing kidney stone surgery, the 120 W MOSES laser technology demonstrated a higher efficiency quotient and significantly reduced the odds of post-operative emergency department visits compared to the 30 W Ho:YAG laser.

Both lasers achieved similar stone clearance rates, but the high-power MOSES laser was associated with fewer auxiliary procedures and retreatments, indicating it may be a more effective option for treating kidney stones in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of high-power holmium laser lithotripsy for pediatric patients with kidney and ureteral stones. Harris, WN., Cao, L., Tasian, GE.[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, 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]

Holmium: YAG laser lithotripsy using a semirigid ureteroscope demonstrated a high overall stone-free rate of 92.2% in a study of 697 patients, with 100% success for distal ureter stones.

The procedure was found to be safe, with only 1.9% of patients experiencing complications, including a low rate of postoperative ureteral stricture at 0.72%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ureteroscopic treatment of ureteral calculi with holmium: YAG laser lithotripsy. Jiang, H., Wu, Z., Ding, Q., et al.[2016]

In a study of 205 patients treated with Holmium:YAG laser lithotripsy for ureteral stones, the procedure was successful in fragmenting or removing stones in 95.2% of cases, demonstrating its efficacy as a treatment option.

While the procedure is generally safe, there were some complications, including ureteral perforation in 1.5% of patients and proximal migration of stone fragments in 1.9%, which were managed effectively with additional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of ureteral stones using Holmium:YAG laser. Ilker, Y., Ozgür, A., Yazici, C.[2018]

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. liebertpub.com liebertpub.com/doi/full/10.1089/end.2021.0592

The Efficiency of Moses Technology Holmium Laser for ... Prior studies assessing factors that influence Ho:YAG laser lithotripsy efficiency demonstrated varied results. Two studies found stone density was a predictor ...

3. mdpi.com mdpi.com/2077-0383/11/16/4828

Moses and Moses 2.0 for Laser Lithotripsy: Expectations vs ... The clinical experiences confirmed that the MT (1.0) has a shorter lasing time but lower laser efficacy, because it consumes more J/mm 3 when compared with the ...

4. cureus.com cureus.com/articles/378920-next-generation-moses-pulse-modulation-an-evaluation-of-whether-this-is-hype-or-breakthrough

Next-Generation Moses Pulse Modulation: An Evaluation ... This review summarises current comparative findings between Moses™ and conventional holmium:YAG laser in the context of lithotripsy and prostate ...

5. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003050

Pulse-modulated Holmium:YAG Laser vs the Thulium Fiber ... The primary outcome was the ureteroscope time required to adequately fragment stones to 1 mm or less. Secondary outcomes were stone-free rate, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9409732/

Moses and Moses 2.0 for Laser Lithotripsy: Expectations vs ... Given the current evidence that we have, there are no high-quality studies that support the use of HP Ho:YAG lasers with MT over other lasers, ...

7. liebertpub.com liebertpub.com/doi/10.1089/end.2021.0592

The Efficiency of Moses Technology Holmium Laser for ... We examined the relationship of stone volume and density to lithotripsy, lasing times, and energy used to treat a single renal stone.

8. trialx.com trialx.com/clinical-trials/listings/287944/ureteroscopy-with-high-powered-holmiumyag-laser-lithotripsy-with-and-moses-on-or-moses-off/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

Ureteroscopy With High-powered Holmium:Yag Laser ... The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it ...