SOLTIVE Laser vs Ho:YAG Laser for Kidney Stones

(Soltive Stone Trial)

Overseen By Jane Ledesma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Multiple stones, Stones bilaterally, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of lasers, the SOLTIVE Thulium laser and the Ho:YAG laser, to determine which is more effective for treating kidney stones. Researchers seek to identify which laser enhances procedural efficiency while maintaining high success rates and doctor satisfaction. The trial is recruiting individuals diagnosed with a single kidney stone less than 2 cm in size who are considering ureteroscopy, a treatment that uses a laser to break the stone and a basket to remove it. This trial may be suitable for those individuals. As an unphased trial, it offers participants the chance to contribute to valuable research that could improve future kidney stone treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that the SOLTIVE Thulium Fiber Laser is safe for treating kidney stones. Studies indicate it has low rates of complications and the need for additional procedures, so patients usually avoid serious issues and rarely require further treatments. It also effectively removes stones, resulting in fewer follow-up visits.

In contrast, the Ho:YAG Laser has long been the standard treatment for kidney stones. While generally safe, it presents challenges, such as the risk of stones moving during the procedure and possible heat damage to nearby tissues. However, these problems are uncommon.

Both lasers are considered safe, but the SOLTIVE Thulium Fiber Laser might offer benefits, such as reducing procedure time and improving results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SOLTIVE Thulium Fiber Laser and the Ho:YAG Laser because these techniques offer new ways to tackle kidney stones. The SOLTIVE Thulium Fiber Laser is unique due to its use of thulium fiber, which allows for more precise and efficient stone fragmentation with potentially less heat generation compared to traditional methods. This could mean a quicker procedure with less risk of damage to surrounding tissues. Meanwhile, the Ho:YAG Laser is a well-established method known for effectively breaking down stones. By comparing these lasers, researchers hope to determine which offers the best outcomes for patients, potentially improving recovery times and overall treatment effectiveness.

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

This trial will compare the SOLTIVE Thulium Fiber Laser and the Ho:YAG Laser for treating kidney stones. Studies have shown that the SOLTIVE Thulium Fiber Laser can significantly enhance kidney stone treatment by reducing procedure times by about 20% and safely and effectively breaking down stones. Meanwhile, the Ho:YAG Laser is a well-established method for removing kidney stones, with many studies supporting its success and low risk of complications. Both lasers perform well, with similar rates of patients being stone-free after treatment. The choice between them may depend on specific advantages like shorter procedure times and ease of use. ^{2 4 6 7 8}

Who Is on the Research Team?

Wilson Molina, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a single kidney stone smaller than 2cm who choose to have it removed using ureteroscopy with laser lithotripsy and extraction. It's not for those with stones larger than 2cm, multiple or bilateral stones, or patients preferring natural stone passage.

Inclusion Criteria

I am choosing to have a specific procedure to remove kidney stones using lasers and a basket.

I have been diagnosed with a kidney stone smaller than 2.0 cm.

Exclusion Criteria

I want to keep participating in the clinical trial.

I have kidney stones larger than 2 centimeters.

I have more than one kidney stone or stones in both kidneys.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopy with laser lithotripsy using either SOLTIVE Thulium Fiber Laser or Ho:YAG Laser

1 day

1 visit (in-person)

Follow-up

Participants are monitored for stone-free rate and post-operative outcomes, including complications and physician satisfaction

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ho:YAG Laser
• Percutaneous nephrolithotomy
• SOLTIVE Thulium Fiber Laser

Trial Overview The study compares two types of lasers used in kidney stone treatment: the new SOLTIVE Thulium Fiber Laser versus the traditional Ho:YAG Laser. The goal is to see which one offers better surgery outcomes and physician satisfaction.

How Is the Trial Designed?

Group I: Ho:YAG Laser Active Control 1 Intervention

Ho:YAG Laser group (laser B)

Group II: SOLTIVE Thulium Fiber Laser Active Control 1 Intervention

SOLTIVE Thulium Fiber Laser group (laser A)

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548292/

Efficacy of Holmium: Yttrium-Aluminum-Garnet (YAG) Laser ... Numerous studies have demonstrated that Ho: YAG laser lithotripsy is highly successful with fewer complication rates; however, factors such as ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12067686/

comparison of super pulsed thulium laser and holmium ... The results of clinical studies showed that the two methods were comparable in the ablation rate, laser time and operative time, stone-free rate ...

3. renalandurologynews.com renalandurologynews.com/reports/kidney-stone-holmium-yag-thulium-fiber-laser-similarly-effective-treatment-risk/

Holmium:YAG vs Thulium Fiber Laser Similarly Effective for ... For patients with 4mm or less residual fragments, the stone-free rate was 78.6% with Ho:YAG 44 vs 88.2% with TFL 45. Results did not differ by ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0090429525003152

Trilogy vs 100 W Ho: YAG Laser for Lithotripsy in Mini- ... In our randomized controlled trial, Trilogy demonstrated significantly greater efficacy than the 100 W Ho:YAG laser, as reflected by a higher SFR (88.4% vs 70% ...

5. frontiersin.org frontiersin.org/journals/physics/articles/10.3389/fphy.2025.1590456/full

Application status of holmium and thulium fiber laser for ... However, in clinical applications, Ho:YAG lasers still face limitations such as calculi displacement, risk of thermal damage, and restricted ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12412774/

A Comparative Evaluation of Holmium:YAG and Thulium ... Laser lithotripsy has transformed the management of urinary stone disease, with Holmium:YAG (Ho:YAG) long regarded as the standard of care.

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08362-9

Clinical efficacy and safety of the superpulse thulium fiber ... This study aims to evaluate and compare the clinical efficacy and safety of the SP TFL and HO:YAG for URS lithotripsy in the treatment of upper urinary calculi.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07012941?term=AREA%5BConditionSearch%5D(%22Ureterolithiasis%22)&rank=9

Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG ... The holmium laser is currently considered the gold standard for lithotripsy on urinary lithiasis, whereas the super-pulsed thulium fibre laser is a ...