Holmium vs Thulium Lasers for Kidney Stones

(HOTLaser Trial)

Overseen By Evelyn James, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MaineHealth

Must not be taking: Buprenorphine, Methadone

Disqualifiers: Pregnancy, BMI >45, Opioid use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Procedure duration

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two laser treatments for kidney stones to determine which is more effective. It examines the use of the holmium laser and the thulium laser in treating medium-to-large kidney stones through a procedure called mini PCNL. Individuals scheduled for this procedure with kidney stones measuring between 1 cm and 3 cm may be suitable candidates. The trial aims to identify which laser more effectively breaks down the stones. As an unphased trial, it provides participants the chance to contribute to advancing medical knowledge and improving future kidney stone treatments.

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 currently prescribed buprenorphine or methadone, you cannot participate.

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

Research has shown that both holmium and thulium lasers are generally safe for treating kidney stones. The Lumenis Pulse 120H holmium laser allows many patients to have their catheter removed on the same day, indicating it is well-tolerated and has a high success rate. This makes it a reliable choice for laser lithotripsy, a procedure that breaks down kidney stones.

Similarly, the thulium fiber laser (TFL) is also safe and effective. Studies indicate it breaks down kidney stones well and maintains a good safety record. Recent analysis shows that TFL not only clears stones effectively but does so with few complications.

Overall, both laser treatments safely remove kidney stones, with evidence supporting their effectiveness and patient tolerance. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these laser treatments for kidney stones because they offer promising advancements over traditional methods. The Thulium Laser, using the Olympus Soltive SuperPulsed Thulium Fiber Laser, is known for its precision and efficiency, potentially reducing treatment times and improving patient recovery compared to standard Holmium lasers. Meanwhile, the Holmium Laser in this trial, the Lumenis Pulse 120H Moses 2.0, features enhanced energy delivery, which could result in more effective stone fragmentation and less tissue damage. These innovations may lead to quicker, safer, and more effective kidney stone removal, which is why they are generating interest in the medical community.

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

This trial will compare the effectiveness of the Lumenis Pulse 120H Moses 2.0 holmium laser and the Olympus Soltive SuperPulsed thulium fiber laser for treating kidney stones. Research has shown that the Lumenis Pulse 120H Moses 2.0 holmium laser effectively breaks down kidney stones, making the procedure about 20% faster than regular holmium lasers due to its advanced technology. Clinical experiences have demonstrated its efficiency in breaking stones into smaller pieces. Meanwhile, the Olympus Soltive SuperPulsed thulium fiber laser is also highly effective in treating kidney stones. Studies indicate that it can speed up procedures and improve patient outcomes. This laser is considered a potential breakthrough due to its safety and effectiveness in breaking down stones. Both lasers show promising results in managing kidney stones, each offering unique benefits in terms of speed and efficiency. Participants in this trial will be randomized to receive treatment with either the holmium or thulium laser. ^{1 2 3 4 6}

Who Is on the Research Team?

David W Sobel, MD

Principal Investigator

MaineHealth

Are You a Good Fit for This Trial?

This trial is for individuals with medium-to-large kidney stones who are candidates for a minimally invasive surgical procedure called mini PCNL. Specific eligibility details aren't provided, but typically participants should be in stable health and meet certain criteria set by the surgeon.

Inclusion Criteria

Able to give informed consent

I have kidney stones, with the largest being between 1cm and 3cm.

I am 21 years old or older.

Exclusion Criteria

Inability to give informed consent

Body Mass Index (BMI) >45

Pregnant or breastfeeding patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants are randomized to be treated using either the holmium or thulium laser for their procedure

Procedure duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

8-12 weeks

Extended Follow-up

Participants are monitored for retreatment rate and adverse events

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Holmium Laser
• Thulium Laser

Trial Overview The study compares two types of lasers used in kidney stone surgery: the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser and the Olympus Soltive Superpulsed thulium fiber laser (TFL). Patients will be randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: Thulium Laser Active Control 1 Intervention

Participants in this arm are randomized to be treated using the Olympus Soltive SuperPulsed Thulium Fiber Laser

Group II: Holmium Laser Active Control 1 Intervention

Participants in this arm are randomized to be treated using the Lumenis Pulse 120H Moses 2.0 Holmium Laser

Who Is Running the Clinical Trial?

MaineHealth

Lead Sponsor

Trials

76

Recruited

43,800+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

The SuperPulsed Thulium fiber laser offers significant advantages over the traditional Holmium:YAG lasers for laser lithotripsy, including a broader range of pulse energy and frequency, leading to faster stone ablation rates (1.5 to 4 times faster) and the production of finer stone dust.

This new laser technology is thermodynamically safe when used with proper irrigation flow and power settings, making it a promising option for ureteroscopic stone dusting and addressing limitations of previous laser systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SuperPulsed Thulium fiber laser: The ultimate laser for lithotripsy? Keller, EX., Traxer, O.[2020]

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 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]

In a study of 126 pediatric patients undergoing retrograde intrarenal surgery for kidney stones, both thulium fiber laser (TFL) and high-power Holmium:YAG laser were found to be safe and effective, with similar stone-free rates (81.4% for Holmium:YAG vs. 89.7% for TFL).

The TFL group had a significantly shorter operative time (49.5 minutes) and a lower re-intervention rate (6.89%) compared to the Holmium:YAG group (64.3 minutes and 14.4%, respectively), suggesting TFL may offer advantages in surgical efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing outcomes of thulium fiber laser versus high-power Holmium:YAG laser lithotripsy in pediatric patients managed with RIRS for kidney stones. A multicenter retrospective study. Candela, L., Solano, C., Castellani, D., et al.[2023]

Citations

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

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 ...

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

Lumenis Pulse™ 120H - Holmium Laser Lithotripsy As shown in a randomized clinical trial, compared with regular Holmium pulse, MOSES Technology can reduce lithotripsy procedure time by nearly 20%, making your ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/93/NCT06266793/Prot_SAP_000.pdf

Comparison of Lumenis Pulse™ 120H Moses 2.0 holmium ... 2 Hypothesis. Primary: Our hypothesis is that the Lumenis Pulse P120H holmium laser will have decreased lasing time compared to the Olympus ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5652929/

Initial Clinical Experience with a Modulated Holmium Laser ... The new Moses laser technology demonstrated good stone fragmentation capabilities when used in everyday clinical practice.

5. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/eu/urology/versatile-bph-portfolio/lumenis-120H-brochure-lr.pdf

Lumenis PulseTM 120H and 60H Holmium Laser Systems ... Efficiency and Clinical Outcomes of Moses Technology with Flexible. Ureteroscopic Laser Lithotripsy for Treatment of Renal Calculus. Urol Int. 2021;105(7-8):587 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11334132/

YAG laser with MOSES versus non ... We compare the outcomes of ureteroscopy and laser stone fragmentation (URSL), using Holmium:YAG laser with MOSES vs Non-MOSES technology.