What side effects are associated with this type of intervention?

Laser lithotripsy, including treatments like the SOLTIVE Thulium laser, is generally well-tolerated but can have some side effects. Common side effects include hematuria (blood in the urine), discomfort or pain during urination, and possible urinary tract infections. In rare cases, there can be injury to the urinary tract, leading to strictures or scarring. Other general treatments for kidney stones, such as extracorporeal shock wave lithotripsy (ESWL), may also cause bruising, pain, and potential damage to surrounding organs.

What prior FDA approvals exist?

Laser lithotripsy, including the use of Holmium:YAG (Ho:YAG) lasers, has been FDA-approved for the treatment of kidney stones. This method involves using laser energy to break down stones into smaller fragments that can be passed naturally. The SOLTIVE Thulium laser, currently being studied, is another form of laser lithotripsy that aims to offer a more efficient procedure with comparable stone-free rates to the Ho:YAG laser. Both treatments are minimally invasive and have been shown to be effective in managing urolithiasis.

What other types of research exist?

A promising alternative to the SOLTIVE Thulium laser for kidney stone treatment is the Holmium:YAG (Ho:YAG) laser. The Ho:YAG laser is well-established and known for its effectiveness in breaking down kidney stones. Additionally, advancements in laser technology and techniques such as high-power Ho:YAG lasers and Moses technology, which improves stone fragmentation and reduces retropulsion, are also noteworthy alternatives for patients considering treatment in 2024.

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Holmium Laser

SOLTIVE Laser vs Ho:YAG Laser for Kidney Stones (Soltive Stone Trial)

N/A

Recruiting

Led By Wilson Molina, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must opt for definitive treatment with ureteroscopy with laser lithotripsy and stone basket extraction

Patients must be diagnosed with single stone burden <2.0 cm

Must not have

Patient with stones >2.0cm

Patients with multiple stones or stones bilaterally

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from both laser treatments may include discomfort during urination, bleeding, possible infection risk, and temporary pain or soreness in the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have kidney stones larger than 2 centimeters.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinary Bladder Calculi (disorder)

Secondary study objectives

To compare Operation time SOLTIVE Thulium Fiber Laser vs Ho:YAG Laser.

Thulium

To compare laser time SOLTIVE Thulium Fiber Laser vs Ho:YAG Laser.

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Ho:YAG LaserActive Control1 Intervention

Ho:YAG Laser group (laser B)

Group II: SOLTIVE Thulium Fiber LaserActive Control1 Intervention

SOLTIVE Thulium Fiber Laser group (laser A)

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Laser lithotripsy, including the SOLTIVE Thulium laser and the Holmium:YAG laser, works by emitting high-energy laser pulses to fragment kidney stones into smaller pieces that can be naturally expelled through the urinary tract. The SOLTIVE Thulium laser is designed to provide a more efficient procedure with similar stone-free rates and potentially higher physician satisfaction compared to the Holmium:YAG laser. This matters for kidney stone patients as it offers a minimally invasive treatment option that can reduce procedure time, improve outcomes, and enhance overall treatment experience.

Urolithiasis: phytotherapy as an adjunct therapy.