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

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a single institution, single surgeon, randomized controlled trial to evaluate the Boston Scientific Lumenis Pulse 120H Moses 2.0 holmium laser versus the Olympus Soltive Superpulsed thulium fiber laser (TFL) for medium-to-large stones in the mini PCNL setting.

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 it safe to use Holmium and Thulium lasers for kidney stones?

Both Holmium and Thulium lasers are generally safe for treating kidney stones in humans. The Thulium laser is noted for its precise and efficient stone removal, with a high degree of safety when used with proper irrigation and power settings. Studies have shown that both lasers are thermodynamically safe and effective for lithotripsy (breaking down kidney stones). ^{1 2 3 4 5}

How do Holmium and Thulium lasers differ in treating kidney stones?

The Thulium fiber laser is a newer technology that offers more efficient stone vaporization compared to the traditional Holmium:YAG laser, due to its higher energy absorption in water. It also allows for a broader range of pulse energy and frequency, leading to faster and more precise stone removal with finer dust, making it a potentially more effective option for kidney stone treatment. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Holmium Laser and Thulium Laser for kidney stones?

Research shows that both the Holmium:YAG laser and the Thulium fiber laser are effective in breaking down kidney stones during procedures, with similar success rates in making patients stone-free and comparable safety profiles. ^{1 4 5 8 9}

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

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]

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]

Citations

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

Pulse-modulated Holmium:YAG Laser vs the Thulium Fiber Laser for Renal and Ureteral Stones: A Single-center Prospective Randomized Clinical Trial. [2023]

2. 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]

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

Holmium:YAG (lambda = 2,120 nm) versus thulium fiber (lambda = 1,908 nm) laser lithotripsy. [2013]

4. United States 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. [2023]

5. Italy 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. [2023]

6. Spain pubmed.ncbi.nlm.nih.gov

SuperPulsed Thulium fiber laser: The ultimate laser for lithotripsy? [2020]

7. Turkey pubmed.ncbi.nlm.nih.gov

Incidence of Ureteric strictures Following Ureteroscopic Laser Lithotripsy: Holmium:YAG Versus Thulium Fiber Laser. [2023]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Retrograde intrarenal surgery using a 1.94 m superpulsed thulium fiber laser]. [2021]

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

Thulium fiber laser lithotripsy using tapered fibers. [2013]