TFL vs MOSES Laser for Kidney Stones

Overseen By Shalyn Littlefield, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thunder Bay Regional Health Research Institute

Must not be taking: Anticoagulants

Disqualifiers: Ureteral stones, Pregnancy, Solitary kidney, others

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

Compensation: Varies

Number of Visits: 3

Duration: Intraoperative

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of lasers to determine which better treats kidney stones. It compares the MOSES Holmium Laser with the Thulium Fibre Laser (TFL) to assess effectiveness and safety. Individuals with single kidney stones between 10-20 mm or multiple stones in one area may qualify. Those dealing with these kidney stones and who have not undergone other treatments like shock wave therapy for the same stone might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from advanced laser treatments.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulants or blood thinners, they must be withheld before surgery.

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

Previous studies have shown that the MOSES Holmium Laser reduces retropulsion by 50%, potentially preventing excessive movement of kidney stones during treatment. This can smooth the procedure and possibly reduce risks.

Research indicates that the Thulium Fibre Laser (TFL) is safe and effective for breaking up kidney stones. It has been described as a potential breakthrough in treatment, offering a high success rate with few complications.

Both lasers have been studied for kidney stone treatment and have demonstrated promising safety results, indicating they are generally well-tolerated with few reported side effects. ^{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 potentially better efficiency and precision compared to traditional options. The MOSES Holmium Laser is designed to minimize stone retropulsion, allowing for more effective fragmentation and potentially reducing procedure time. The Thulium Fibre Laser (TFL), on the other hand, operates at a lower energy level, which could lead to less damage to surrounding tissues and faster operation speeds. Both lasers represent a leap forward in targeting and treating kidney stones with greater accuracy and reduced recovery times.

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

In this trial, participants will receive treatment with either the MOSES Holmium Laser or the Thulium Fibre Laser (TFL). Previous studies have shown that the MOSES Holmium Laser reduces retropulsion by 50%, meaning kidney stones move less during treatment. This stability makes the stones easier to break up. Research on the Thulium Fibre Laser (TFL) indicates it is effective and safe for treating kidney stones, with many patients becoming stone-free. TFL is considered a promising new option for managing kidney stones. Both lasers aim to efficiently break down stones, each offering unique strengths in treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Hazem Elmansy, MD

Principal Investigator

Urologist

Are You a Good Fit for This Trial?

This trial is for adults over 18 with kidney stones sized 10-20 mm or multiple stones in one calyx. They must understand and consent to the study, be able to follow its procedures, and not have had previous shock wave treatments for the same stone. Pregnant individuals, those with certain preexisting conditions, a solitary kidney, additional ureteral stones or strictures, very large or numerous differently located stones, untreated urinary infections or uncorrected bleeding disorders are excluded.

Inclusion Criteria

I have kidney stones that are 10-20 mm large or multiple stones in one area.

Ability to comply with the requirements of the study procedures

Written informed consent to participate in the study

Exclusion Criteria

I have a stone or narrowing in the tube on the same side as my bladder.

You have kidney stones that are larger than 20 mm or have multiple stones in different parts of your kidney.

I do not have an active urinary tract infection, or it is being treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treatment using either the MOSES Holmium laser or the Thulium Fiber Laser (TFL) for kidney stone management

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for stone-free rate and post-op complications

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MOSES Holmium Laser
• Thulium Fibre Laser

Trial Overview The study compares two laser technologies: Thulium Fiber Laser (TFL) and MOSES Holmium Laser in treating kidney stones. It aims to determine which laser is more effective and safe for patients requiring removal of these stones through ureteroscopy.

How Is the Trial Designed?

Group I: Thulium Fibre Laser (TFL) Experimental Treatment 1 Intervention

Patients randomized to this arm will undergo treatment using the TFL.

Group II: MOSES Holmium Laser Experimental Treatment 1 Intervention

Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.

MOSES Holmium Laser is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Approved in European Union as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Approved in Canada as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Who Is Running the Clinical Trial?

Thunder Bay Regional Health Research Institute

Lead Sponsor

Trials

11

Recruited

860+

Thunder Bay Regional Research Institute

Lead Sponsor

Trials

9

Recruited

620+

Published Research Related to This Trial

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]

The Thulium fiber laser (TFL) demonstrated longer ureter perforation times compared to the Holmium:YAG laser, suggesting it may be safer for use in lithotripsy procedures, with mean perforation times of 7.9, 3.8, and 1.8 seconds at pulse rates of 150, 300, and 500 Hz, respectively.

TFL showed reduced collateral damage to ureter tissue and stone baskets, with no damage observed at working distances greater than 1.0 mm, indicating a potentially greater safety margin compared to the standard Holmium:YAG laser.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collateral damage to the ureter and Nitinol stone baskets during thulium fiber laser lithotripsy. Wilson, CR., Hardy, LA., Irby, PB., et al.[2016]

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]

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 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]

The Lumenis® High-power Holmium Laser with Moses technology showed promising stone fragmentation capabilities, achieving a rate of 95.8 mm3/min compared to 58.1 mm3/min without the technology, although this difference was not statistically significant.

Surgeons rated the Moses technology as better or much better in 17 out of 23 procedures, indicating a positive perception of its effectiveness in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Clinical Experience with a Modulated Holmium Laser Pulse-Moses Technology: Does It Enhance Laser Lithotripsy Efficacy? Mullerad, M., Aguinaga, JRA., Aro, T., et al.[2020]

The SuperPulse Thulium fiber laser (SP TFL) is an effective and safe treatment for small calyceal stones in the lower pole of the kidney, achieving a stone-free rate of 86.6% after 90 days in a study of 15 patients.

The use of small laser fibers allows for better maneuverability during flexible ureteroscopy, enabling successful treatment even in challenging anatomical conditions, with a low complication rate of 6.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Flexible ureteroscopy for lower pole renal stones: novel superpulse thulium (TM) fiber laser lithotripsy]. Rapoport, LM., Gazimiev, MA., Korolev, DO., et al.[2021]

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]

In a study involving 102 patients undergoing mini-percutaneous nephrolithotomy for kidney stones, both high-power holmium laser with MOSES technology (HPH-M) and thulium fiber laser (TFL) demonstrated similar stone-free rates (SFR) after 48 hours, with HPH-M achieving 78.43% and TFL 68.63%.

While both lasers were comparable in fragmentation efficiency and dusting of stone fragments, TFL produced a higher proportion of larger fragments (>3 mm) compared to HPH-M, indicating that while both methods are effective, HPH-M may be more efficient in minimizing larger residual stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Power Holmium with MOSES Technology or Thulium Fiber Laser in MiniPerc with Suction: A New Curiosity. Patil, A., Reddy, N., Shah, D., et al.[2022]

Citations

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

Lumenis Pulse™ 120H - Holmium Laser Lithotripsy MOSES Technology displayed 50% reduction in retropulsion compared to standard Holmium pulse, potentially minimizing incidents of ureteral stone migration into ...

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

Moses and Moses 2.0 for Laser Lithotripsy: Expectations vs ... This laser developed by Lumenis is a 120 W holmium laser (Lumenis PulseTM 120 H; Lumenis, San Jose, CA, USA) that can reach up to 80 Hz.

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

Comparison of Lumenis Pulse™ 120H Moses 2.0 holmium ... Studies have begun to compare TFL to high power holmium with Moses™ technology for ureteroscopy and laser lithotripsy (URSLL), however, data is ...

4. 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): ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9181640/

New Generation Pulse Modulation in Holmium:YAG Lasers Efficiency and Clinical Outcomes of Moses Technology with Flexible Ureteroscopic Laser Lithotripsy for Treatment of Renal Calculus. Urol. Int. 2021;157:587 ...

6. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/laser-therapies/moses-technology.html

Lumenis Pulse™ 120H Holmium Laser System Treat kidney stones and BPH with the Lumenis Pulse 120H Holmium Laser System with MOSES 2.0 Technology. It delivers remarkable efficiency and versatility.

7. daytonphysicians.com daytonphysicians.com/holmium-laser-moses-2-0/

Holmium Laser MOSES 2.0 MOSES 2.0 Pulse 120H holmium laser, is a new system by Israeli medical device company Lumenis Ltd. that provides advances in treatment for kidney stones and ...