What side effects are associated with this type of intervention?

Extracorporeal Shock Wave Lithotripsy (SWL), a common treatment for kidney stones similar to Burst Wave Lithotripsy (BWL), can have side effects such as pain, bruising, and discomfort at the treatment site. Other potential side effects include hematuria (blood in the urine), infection, and, in rare cases, damage to surrounding organs or tissues. Patients may also experience the passage of stone fragments, which can cause discomfort or urinary obstruction.

What prior FDA approvals exist?

The FDA has approved extracorporeal shock wave lithotripsy (SWL) for the treatment of kidney stones, which uses high amplitude shock waves to fragment stones. This method is somewhat similar to Burst Wave Lithotripsy (BWL), which employs low amplitude ultrasound bursts. While BWL is still under investigation, SWL remains a widely used and established treatment for kidney stones.

What other types of research exist?

Promising novel alternatives to Burst Wave Lithotripsy for kidney stone treatment include: 1) Low-Intensity Extracorporeal Shockwave Therapy (Li-ESWT), which uses lower intensity shockwaves to fragment stones with potentially fewer side effects. 2) Advanced laser lithotripsy techniques, such as thulium fiber laser lithotripsy, which offer precise stone fragmentation with minimal tissue damage. 3) Micro-Percutaneous Nephrolithotomy (Micro-PCNL), a minimally invasive surgical technique that allows for direct access and removal of kidney stones with reduced recovery time.

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Ultrasound Lithotripsy

Burst Wave Lithotripsy for Kidney Stones

Q: What is the mechanism of action of this treatment?

Common treatments for kidney stones, such as Burst Wave Lithotripsy (BWL) and Extracorporeal Shock Wave Lithotripsy (SWL), work by using sound waves to break down stones into smaller fragments that can be more easily passed through the urinary tract. BWL employs multi-cycle bursts of low amplitude ultrasound, which can effectively fracture stones with potentially less damage to surrounding tissues compared to the high amplitude shock waves used in SWL. This matters for patients as these non-invasive methods can reduce recovery time, minimize pain, and lower the risk of complications associated with more invasive surgical procedures.

N/A

Waitlist Available

Led By Michael R Bailey, PhD, MS

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Individuals scheduled for clinical stone removal via ureteroscopy (URS)

Be older than 18 years old

Must not have

Individuals under 18 years of age

Individuals with a solitary kidney

Timeline

Screening 3 weeks

Treatment Varies

Follow Up out to 120 days post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new method called BWL that uses gentle ultrasound waves to break kidney stones in patients with stones 12 mm or smaller. The patients are already under anesthesia for a standard stone removal procedure. BWL works by using many softer waves to crack the stones.

Who is the study for?

This trial is for adults with visible kidney stones on a CT scan, who are already scheduled to have stone removal via ureteroscopy. It's not for those under 18, pregnant women, mentally disabled individuals, prisoners, people with bleeding disorders or taking significant anticoagulants, or anyone with certain calcified aneurysms or just one kidney.

What is being tested?

The study is testing Burst Wave Lithotripsy (BWL), a new technique using bursts of low amplitude ultrasound to break up kidney stones. This differs from the high amplitude shock waves used in traditional methods. The trial will see if BWL can effectively fragment stones during surgery.

What are the potential side effects?

Since this is a feasibility study focusing on the effectiveness of BWL in breaking up kidney stones during surgery, specific side effects related to the procedure may vary and will be documented as part of the trial outcomes.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for a procedure to remove kidney stones using a scope.

Exclusion Criteria

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

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I am under 18 years old.

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I have only one kidney.

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I am currently on a significant dose of blood thinners.

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I have a bleeding disorder that hasn't been treated.

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I have a calcified aneurysm in my abdomen or kidney.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ out to 120 days post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~out to 120 days post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and out to 120 days post-procedure for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Effectiveness - Volume of Fragments < 2 mm

Safety - Area of Tissue Injury

Secondary study objectives

Effectiveness - Time to Full Comminution

Safety - Adverse Event Assessment

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.

0 / 6Eligibility 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

Common treatments for kidney stones, such as Burst Wave Lithotripsy (BWL) and Extracorporeal Shock Wave Lithotripsy (SWL), work by using sound waves to break down stones into smaller fragments that can be more easily passed through the urinary tract. BWL employs multi-cycle bursts of low amplitude ultrasound, which can effectively fracture stones with potentially less damage to surrounding tissues compared to the high amplitude shock waves used in SWL. This matters for patients as these non-invasive methods can reduce recovery time, minimize pain, and lower the risk of complications associated with more invasive surgical procedures.

Quantitation of response to therapy in calcium urolithiasis.[High energy shockwave-induced acute changes in renal function].