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

Trial Summary

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 data supports the effectiveness of the treatment Laser Lithotripsy for Kidney Stones?

Research shows that the Moses technology in Holmium laser lithotripsy reduces the time needed for procedures and minimizes stone movement, which can make the treatment more efficient and potentially save costs. Additionally, high-power Holmium:YAG lasers are effective for treating large kidney stones, and using advanced techniques like angled optical fibers can speed up the process. ^{1 2 3 4 5}

Is laser lithotripsy safe for treating kidney stones?

Research shows that laser lithotripsy, including the Moses technology, is generally safe for treating kidney stones, with no significant differences in complications compared to conventional methods. ^{1 2 5 6 7}

How is the Dusting treatment for kidney stones different from other treatments?

The Dusting treatment, using Moses Holmium:YAG laser technology, is unique because it minimizes stone movement and improves stone breaking without direct contact, potentially reducing procedure time and costs compared to traditional methods. ^{1 2 3 8 9}

What is the purpose of this trial?

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 will affect time in the operating room, time using the laser, laser energy, and stone free rates. Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology. The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.

Research Team

Amy Krambeck, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

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

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

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

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

3. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of high-power holmium laser lithotripsy for pediatric patients with kidney and ureteral stones. [2023]

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

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

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

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

6. 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]

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

Ureteroscopic treatment of ureteral calculi with holmium: YAG laser lithotripsy. [2016]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of ureteral stones using Holmium:YAG laser. [2018]

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

Ureteroscopic Laser Lithotripsy: A Review of Dusting vs Fragmentation with Extraction. [2019]