Laser Systems for Kidney Stones

Overseen By Jade McDermott, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Concomitant stones, Prior procedures, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two laser systems to determine which is more effective at breaking up kidney stones during ureteroscopy. The Thulio Pulsed Thulium:YAG (p-Tm:YAG) laser is a new system, while the Thulium Fiber Laser (TFL) has been previously used. Candidates may include individuals with a single kidney stone or a group of stones measuring 7 to 20 mm who are suitable for surgery. The study aims to identify which laser is more efficient and effective for treating kidney stones. As an unphased trial, it offers patients the chance to contribute to medical advancements 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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these laser systems are safe for kidney stone treatment?

Earlier studies found the Thulio Pulsed Thulium:YAG (p-Tm:YAG) laser effective and safe for treating kidney stones. Patients reported it was easy to tolerate, with no major safety issues. Another study confirmed its efficacy and safety in breaking down urinary stones, comparable to other well-known laser systems.

Research on the Thulium Fiber Laser (TFL) also shows it is safe and effective for treating kidney stones. Studies indicate it works well with few side effects, making it a reliable choice for patients undergoing laser treatment for kidney stones.

Both laser systems have demonstrated promising safety records in past research, making them potential options for those considering joining clinical trials for kidney stone treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these laser systems for treating kidney stones because they offer unique advantages over traditional options like shock wave lithotripsy and Holmium:YAG lasers. The Thulio pulsed Thulium:YAG (p-Tm:YAG) laser system is designed to deliver more precise energy, potentially reducing damage to surrounding tissues and improving stone fragmentation. The Thulium Fiber Laser (TFL) is known for its efficiency, requiring less energy while providing consistent results, which can lead to faster procedures and quicker recovery times. These innovations could make treatment less invasive and more comfortable for patients, which is why there's a buzz in the medical community.

What evidence suggests that this trial's laser systems could be effective for kidney stone treatment?

This trial will compare two laser systems for kidney stone treatment. Participants in one arm will receive the Thulio Pulsed Thulium:YAG (p-Tm:YAG) laser, which studies have shown to be safe and efficient for treating urinary stones. Research indicates it performs very well in kidney stone procedures. Participants in the other arm will receive the Thulium Fiber Laser (TFL), recognized as a top choice with high success rates in achieving stone-free outcomes after treatment. It represents a major advancement in treating kidney stones. Both lasers are promising tools for effectively removing kidney stones. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with kidney stones who can consent to treatment and are good candidates for a specific type of surgery called flexible ureteroscopy. Surgeons involved must be specialized in Endourology. Participants should have a single kidney stone or multiple stones totaling 7-20 mm in size, but those with certain urinary conditions, pregnancy, untreated UTI, other stones, prior surgeries or radiotherapy to the area cannot join.

Inclusion Criteria

Must be able to give consent

My surgeon is a trained specialist in Endourology.

I am considered fit for a specific kidney stone removal surgery.

Exclusion Criteria

Pregnancy

I have a bladder condition due to nerve problems or a spinal cord injury.

I currently have a urinary tract infection that hasn't been treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopic stone treatment using either the p-Tm:YAG or TFL laser systems

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up imaging

6-12 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Thulio Pulsed Thulium:YAG (p-Tm:YAG)
• Thulium Fiber Laser (TFL)

Trial Overview The study compares two laser systems used during ureteroscopy: Thulium Fiber Laser (TFL) and pulsed Thulium:YAG (p-Tm:YAG). It aims to determine which system is more effective at breaking up kidney stones during this minimally invasive procedure.

How Is the Trial Designed?

Group I: p-Tm:YAG laser system Experimental Treatment 1 Intervention

This is a new laser system developed by Dornier, the Thulio pulsed Thulium:YAG (p-Tm:YAG)

Group II: TFL laser system Active Control 1 Intervention

The thulium fiber laser (TFL) has demonstrated effectiveness in this procedure.

Thulio Pulsed Thulium:YAG (p-Tm:YAG) is already approved in European Union, United States for the following indications:

Approved in European Union as Dornier Thulio for:

• Kidney stones
• Nephrolithiasis
• Endocorporeal laser lithotripsy (ELL) during retrograde intrarenal surgery (RIRS)

Approved in United States as Dornier Thulio for:

• Kidney stones
• Nephrolithiasis
• Endocorporeal laser lithotripsy (ELL) during retrograde intrarenal surgery (RIRS)

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dornier MedTech Systems

Industry Sponsor

Trials

5

Recruited

340+

Published Research Related to This Trial

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 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]

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 174 patients with ureteral stones, the new super pulse thulium fiber laser (SP TFL) demonstrated a shorter operation time compared to the holmium laser, with an average of 24.7 minutes versus 32.4 minutes.

The SP TFL resulted in a higher stone-free rate at 30 days post-treatment, with no residual stones compared to five cases in the holmium laser group, indicating its superior efficacy in ureterolithotripsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Comparison of Super Pulse Thulium Fiber Laser and High-Power Holmium Laser for Ureteral Stone Management. Martov, AG., Ergakov, DV., Guseynov, M., et al.[2021]

The thulium fiber laser (TFL) in micro-pulse train (MPT) mode significantly increased the stone ablation rates for uric acid and calcium oxalate stones, achieving rates of 414 μg/s and 122 μg/s respectively, compared to lower rates with standard pulse trains.

Minimal stone retropulsion was observed with TFL operation, indicating safety in its application, while fiber degradation was noted to be higher with calcium oxalate stones, suggesting a need for further optimization in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced thulium fiber laser lithotripsy using micro-pulse train modulation. Blackmon, RL., Irby, PB., Fried, NM.[2019]

Thulium fiber laser (TFL) is a safe and effective treatment for breaking down ureteral and renal stones during retrograde intrarenal surgery (RIRS), with a low overall complication rate observed in a study of 50 patients.

The study utilized specific laser settings for different stone types, showing that TFL can be tailored for optimal performance based on stone size and density, enhancing its efficacy in lithotripsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the new thulium fiber laser: first 50 cases. Corrales, M., Traxer, O.[2022]

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 superpulse thulium fiber laser demonstrated superior stone ablation rates compared to the holmium:YAG laser, achieving threefold faster dusting for calcium oxalate stones and 2.5-fold for uric acid stones, indicating its efficacy in lithotripsy.

The thulium fiber laser produced lower retropulsion effects, requiring a higher energy threshold to initiate stone movement, which may enhance safety and precision during procedures compared to the holmium:YAG laser.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical comparison of superpulse thulium fiber laser and a holmium:YAG laser for lithotripsy. Andreeva, V., Vinarov, A., Yaroslavsky, I., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06721975

Thulium Fiber Laser (TFL) vs Thulio Pulsed ... This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456925001695

Mini Review Pulsed Thulium:YAG Laser for Lithotripsy The p-Tm:YAG laser seems to be effective and safe for the treatment of urinary stones and offers a combination of advantages from both Ho:YAG laser and TFL ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7879830/

Outcomes of thulium fibre laser for treatment of urinary tract ... Based on the review, the TFL is a potential game-changer for kidney stone disease and has a promising role in the future.

4. link.springer.com link.springer.com/article/10.1007/s00345-023-04640-4

Pulsed Thulium:YAG laser – What is the lithotripsy ablation ... The present study aimed to evaluate p-Tm:YAG ablation efficiency for stone dust from human urinary stones of known compositions.

5. dornier.com dornier.com/americas/thulio/

Thulio — Dornier MedTech Americas The p-Tm:YAG laser Thulio is both effective and safe in flexible ureteroscopy (fURS) for treating ureteral and renal stones, with excellent outcomes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39286758/

Flexible Ureteroscopic Lithotripsy with the Pulsed Thulium: ... The aim of this study was to assess and validate the clinical laser performance and safety profile of p-Tm:YAG laser in a series of patients ...

7. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06721975

Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p ... This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser ...