Burst Wave Lithotripsy for Kidney Stones

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Burst Wave Lithotripsy for kidney stones?

Research shows that Burst Wave Lithotripsy can effectively break down kidney stones into small fragments that can pass naturally, with studies in pigs showing an average of 87% of stone mass reduced to fragments smaller than 2mm. Additionally, this treatment appears to cause minimal injury to the kidney and urinary tract. ^{1 2 3 4 5}

Is Burst Wave Lithotripsy safe for humans?

Research on Burst Wave Lithotripsy, mostly in animal models, suggests it can break kidney stones into small fragments with minimal injury to the kidney and urinary tract. Some minor surface damage was observed around the stone area, but no significant harm was detected in the kidney tissue. ^{1 3 5 6 7}

How is Burst Wave Lithotripsy treatment different from other kidney stone treatments?

Burst Wave Lithotripsy is unique because it uses focused ultrasound bursts to noninvasively break kidney stones into small fragments that can pass naturally, without surgery or significant pain. This treatment is performed externally and does not cause major injury to the kidney or urinary tract, making it a safer alternative to traditional surgical methods. ^{1 2 3 5 8}

Research Team

Michael R Bailey, PhD, MS

Principal Investigator

University of Washington

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

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

Burst wave lithotripsy and acoustic manipulation of stones. [2022]

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

Recent Advances in the Science of Burst Wave Lithotripsy and Ultrasonic Propulsion. [2023]

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

Detection and Evaluation of Renal Injury in Burst Wave Lithotripsy Using Ultrasound and Magnetic Resonance Imaging. [2018]

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

Combined Burst Wave Lithotripsy and Ultrasonic Propulsion for Improved Urinary Stone Fragmentation. [2019]

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

Evaluation of Renal Stone Comminution and Injury by Burst Wave Lithotripsy in a Pig Model. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Are there long-term effects of extracorporeal shockwave lithotripsy in paediatric patients? [2016]

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

The effectiveness and safety of extracorporeal shock wave lithotripsy for the management of kidney stones: A protocol of systematic review and meta-analysis. [2023]

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

An in vivo demonstration of efficacy and acute safety of burst wave lithotripsy using a porcine model. [2020]