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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares the new SOLTIVE Thulium laser to the traditional Holmium laser for treating kidney stones. The new laser aims to break down stones more efficiently and with less damage to surrounding tissues, potentially improving patient outcomes and reducing costs. The Thulium fibre laser (TFL) has recently been introduced as a new technology and may challenge the Holmium:YAG (Ho:YAG) laser as the preferred option due to its favorable properties.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the SOLTIVE Laser and Ho:YAG Laser treatment for kidney stones?

Research shows that the super pulse thulium fiber laser (similar to the SOLTIVE Laser) is effective and safe for breaking down stones, with no leftover stones in patients after 30 days, compared to some residual stones with the Ho:YAG Laser. This suggests that the SOLTIVE Laser may be a strong alternative to the Ho:YAG Laser for treating kidney stones. ^{1 2 3 4 5}

Is the SOLTIVE Laser safe for treating kidney stones?

The SOLTIVE Thulium Fiber Laser and the Ho:YAG Laser have been studied for safety in treating kidney stones. The Ho:YAG Laser has been used safely for many years, while initial results for the SOLTIVE Laser are encouraging, though some studies have noted potential damage to surrounding tissues. ^{2 3 4 6 7}

How does the SOLTIVE Thulium Fiber Laser treatment for kidney stones differ from other treatments?

The SOLTIVE Thulium Fiber Laser is unique because it uses a superpulsed thulium fiber laser, which allows for lower pulse energy and higher pulse frequencies compared to the traditional Holmium:YAG laser. This results in shorter operation times and potentially fewer complications, making it a promising alternative for kidney stone management. ^{1 4 8 9 10}

Research Team

Wilson Molina, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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.

I am 18 years old or older.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Clinical Comparison of Super Pulse Thulium Fiber Laser and High-Power Holmium Laser for Ureteral Stone Management. [2021]

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

Percutaneous nephrolithotomy with holmium: Yttrium-aluminum-garnet laser and fiber guider--report of 349 cases. [2007]

3. Germany pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the pulsed solid-state thulium YAG laser from Dornier during RIRS: first 25 cases. [2023]

4. Singapore pubmed.ncbi.nlm.nih.gov

Thulium fiber laser lithotripsy: Is it living up to the hype? [2023]

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

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

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

Collateral damage to the ureter and Nitinol stone baskets during thulium fiber laser lithotripsy. [2016]

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

Lasers for stone lithotripsy: advantages/disadvantages of each laser source. [2023]

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

New endourologic technology for simultaneous holmium:YAG laser lithotripsy and fragment evacuation for PCNL: ex-vivo comparison to standard ultrasonic lithotripsy. [2016]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparing dusting and fragmenting efficiency using the new SuperPulsed thulium fiber laser versus a 120 W Holmium:YAG laser. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Comparison of the ablation rates, fissures and fragments produced with 150 µm and 272 µm laser fibers with superpulsed thulium fiber laser: an in vitro study. [2021]