Burst Wave Lithotripsy for Kidney Stones

Not currently recruiting at 1 trial location

Overseen By Michael R Bailey, PhD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants

Disqualifiers: Under 18, Vulnerable groups, Bleeding disorders, Aneurysms, Solitary kidney, 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 tests a new method to break up kidney stones using sound waves, known as Burst Wave Lithotripsy (BWL). Unlike the traditional method, which uses high-energy shock waves, BWL employs gentle, repeated sound waves to fragment the stones. The trial aims to determine if BWL can safely and effectively break up kidney stones in individuals already planning a stone removal procedure. Candidates with a kidney stone visible on a CT scan and scheduled for stone removal surgery might be suitable participants. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for kidney stones.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking a significant dose of blood thinners at the time of the procedure.

What prior data suggests that this method is safe for kidney stone treatment?

Research has shown that Burst Wave Lithotripsy (BWL) is generally safe for breaking down kidney stones. Studies have found that this method causes little harm to the kidney and urinary tract, indicating that most people tolerate it well. In one study, the treatment successfully broke stones into small pieces without causing damage. This ultrasound technique differs from traditional methods and has demonstrated promising safety results. Overall, BWL appears to be a safe option for treating kidney stones based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for kidney stones, which often include shock wave lithotripsy or surgical procedures, burst wave lithotripsy (BWL) offers a unique, non-invasive method that uses focused ultrasound waves to break up kidney stones. Researchers are excited about BWL because it potentially allows for shorter treatment times—just 10 minutes—during a standard lithotripsy procedure. Moreover, BWL could reduce the need for anesthesia and minimize discomfort, making it a promising alternative that could be both more efficient and patient-friendly.

What evidence suggests that Burst Wave Lithotripsy is effective for kidney stones?

Research shows that Burst Wave Lithotripsy (BWL), the treatment under study in this trial, holds promise for breaking kidney stones. Studies have found that BWL can successfully break stones, with 71% of treated stones becoming smaller than 2 mm, indicating that more than half of the stones were completely cleared. Initial findings suggest the treatment is quick, often taking less than 10 minutes, and patients tolerate it well. Additionally, BWL has high success rates, with 88-91% of stones effectively broken into smaller pieces. Overall, BWL appears to be a safe and effective method for treating kidney stones. ^{1 3 4 6 7}

Who Is on the Research Team?

Michael R Bailey, PhD, MS

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have at least one kidney stone visible on a CT scan.

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

Exclusion Criteria

I am under 18 years old.

I have only one kidney.

I am currently on a significant dose of blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the burst wave lithotripsy intervention during their standard-of-care lithotripsy procedure

1 day

1 visit (in-person, intraoperative)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event assessment

16 weeks

Multiple visits (in-person or virtual as needed)

What Are the Treatments Tested in This Trial?

Interventions

• Burst Wave Lithotripsy

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004533

Facilitated Clearance of Small, Asymptomatic Renal ... Twenty-two of 31 stones (71%) met the primary effectiveness outcome of no fragment > 2 mm, with 17 of 31 stones (55%) reported as stone free.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8080914/

First In-Human Burst Wave Lithotripsy for Kidney Stone ... Conclusions: The first-in-human tests of BWL pulses were successful in that a renal stone was comminuted in <10 minutes, and BWL was also tolerated by an awake ...

3. urologytimes.com urologytimes.com/view/bwl-plus-ultrasonic-propulsion-shows-safety-efficacy-for-small-renal-stones

BWL plus ultrasonic propulsion shows safety, efficacy for ... Combination treatment with burst wave lithotripsy (BWL) and ultrasonic propulsion was shown to be an effective and safe method of removing small, asymptomatic ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031800/

Burst wave lithotripsy - a paradigm shift - PubMed Central - NIH Human trials reported BWL as well tolerated in awake patients with high fragmentation success rates (88–91%) and low complication rates. BWL ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03873259

Intraoperative Assessment of of Burst Wave Lithotripsy (BWL) The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume. Day 0 - the day of the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31016998/

Evaluation of Renal Stone Comminution and Injury by ... The data suggest that such exposures produce minimal injury to the kidney and urinary tract.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03811171

Study Details | NCT03811171 | Break Wave(TM) ... This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper ...