HoYAG vs TFL Lasers for Kidney Stones

Overseen By Jane Ledesma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Pregnancy, Immunosuppression, Coagulopathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of lasers, HoYAG (holmium:yttrium-aluminum-garnet laser) and TFL (thulium fiber laser), used in mini percutaneous nephrolithotripsy to treat large kidney stones. The researchers aim to determine which laser is more effective when combined with a vacuum-assisted sheath for removing broken stones. Individuals with kidney stones larger than 1.5 cm who require a specific procedure to break them up may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future kidney stone treatments.

Do I need to stop my current medications for the trial?

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 platforms are safe for kidney stone treatment?

Previous studies found that the HoYAG laser had a complication rate of about 5.4%, similar to the TFL laser. Both lasers are considered safe for breaking kidney stones. Research has shown that both lasers perform effectively and are generally easy for patients to tolerate. The HoYAG laser has been in use for many years, while the TFL laser, though newer, has demonstrated good results with high stone removal rates and few side effects. Both lasers have FDA approval, offering an additional level of safety assurance. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for kidney stones because they use advanced laser technology, offering potential improvements over traditional methods like extracorporeal shock wave lithotripsy (ESWL) and standard ureteroscopy with laser lithotripsy. The HoYAG (Holmium: Yttrium-Aluminum-Garnet) laser is well-regarded for its versatility in fragmenting stones of various compositions. Meanwhile, the TFL (Thulium Fiber Laser) stands out for its precision and energy efficiency, potentially reducing procedure time and minimizing thermal damage to surrounding tissues. These innovative approaches could lead to more effective and safer treatments for patients with kidney stones.

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

This trial will compare the effectiveness of the HoYAG and TFL lasers for treating kidney stones. Participants in one arm will undergo miniPCNL with the HoYAG laser. Studies have shown that this laser effectively breaks down stones with fewer complications, achieving complete removal 78.6% of the time. In another arm, participants will undergo miniPCNL with the TFL laser, considered a potential breakthrough, achieving a complete removal rate of 88.2% for small fragments. Both lasers are promising, but the TFL shows slightly better results in completely removing stones. ^{2 3 5 6 7}

Who Is on the Research Team?

Bristol Whiles, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with kidney stones larger than 2cm who are undergoing mini percutaneous nephrolithotripsy, a common procedure to remove these stones. The study does not specify additional eligibility criteria, so participants should consult the investigators for more details.

Inclusion Criteria

I am over 18 years old.

I have kidney stones larger than 15 mm.

I am scheduled for a specific kidney stone removal surgery.

Exclusion Criteria

Simultaneous use of more than 1 laser platform or other form of fragmentation (e.g., ultrasonic)

Pregnant patients

External urinary catheters

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo mini percutaneous nephrolithotripsy (miniPCNL) with either HoYAG or TFL laser platform using ClearPetra™ vacuum-assisted renal access sheath

Procedure

Follow-up

Participants are monitored for stone-free status and other outcomes post-operatively

90 days

What Are the Treatments Tested in This Trial?

Interventions

• HoYAG
• TFL

Trial Overview The trial compares two FDA-approved laser platforms used in kidney stone treatment: HoYAG and TFL lasers. Both will be tested alongside vacuum-assisted renal access sheaths during the stone removal process to evaluate which provides better outcomes.

How Is the Trial Designed?

Group I: MiniPCNL with TFL Active Control 1 Intervention

In Arm 2, participants will undergo miniPCNL with ClearPetra™ vacuum-assisted ureteral access sheath with TFL laser platform. Participants will undergo miniPCNL per standard of care

Group II: MiniPCNL with HoYAG Active Control 1 Intervention

In Arm 1, participants will undergo miniPCNL with ClearPetra™ vacuum-assisted ureteral access sheath with HoYAG laser platform. Participants will undergo miniPCNL per standard of care

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

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

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. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1477513122002224

Comparative effectiveness of high-power holmium laser ... High-power Ho:YAG laser technology may be beneficial for children undergoing ureteroscopy for ureteral and kidney stones due to the higher efficiency and lower ...

4. cureus.com cureus.com/articles/393761-a-comparative-evaluation-of-holmiumyag-and-thulium-fiber-lasers-in-urinary-stone-treatment

A Comparative Evaluation of Holmium:YAG and Thulium ... For example, Ulvik et al. reported a statistically significant improvement in SFR with TFL (92%) versus Ho:YAG (67%) (p = 0.001) in ...

5. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003050

Pulse-modulated Holmium:YAG Laser vs the Thulium Fiber ... The primary outcome was the ureteroscope time required to adequately fragment stones to 1 mm or less. Secondary outcomes were stone-free rate, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41173535/

High-Power Retrograde Intrarenal Surgery Holmium Laser ... This study evaluates the feasibility, safety, and efficacy of high-power holmium laser retrograde intrarenal surgery (RIRS) for the treatment of ...

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

Trilogy vs 100 W Ho: YAG Laser for Lithotripsy in Mini- ... Such devices provide excellent tissue safety and an optimized aspiration configuration, achieving mean lithotripsy rates of 370.5 ± 171 mm³/min for Mini-PCNL ...