Extracorporeal Lithotripsy for Kidney Stones

(SOUND Trial)

Recruiting at 9 trial locations

Overseen By Emily Hergenreter

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SonoMotion

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Bleeding disorders, UTI, others

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

Compensation: Varies

Number of Visits: 2

116 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the Break Wave™ system, which uses sound waves to break up kidney stones. It targets patients with stones between 4mm and 10mm in size. The goal is to see if the device is safe and effective in making the stones small enough to pass naturally. The Break Wave™ system is a new method of lithotripsy that uses short, broadly focused bursts of ultrasound rather than shock waves to fragment stones.

Will I have to stop taking my current medications?

The trial requires that participants stop taking anticoagulants (blood thinners) if they are on them and are willing to do so for the Break Wave procedure.

What data supports the effectiveness of the treatment Break Wave for kidney stones?

Extracorporeal shock wave lithotripsy (ESWL), a similar treatment to Break Wave, is highly effective for kidney stones smaller than 2 cm, with success rates of 80 to 90 percent. This suggests that Break Wave, if similar to ESWL, could also be effective for treating kidney stones. ^{1 2 3 4 5}

Is extracorporeal shock wave lithotripsy safe for humans?

Extracorporeal shock wave lithotripsy is generally considered very safe for treating kidney stones, with serious complications being rare and affecting less than 1% of patients. Minor complications can occur, but the treatment is safe for both adults and children in the long term. ^{6 7 8 9 10}

How is the Break Wave treatment for kidney stones different from other treatments?

The Break Wave treatment, also known as extracorporeal shock wave lithotripsy, is unique because it uses shockwaves to break kidney stones into tiny particles that can be passed naturally through urination, avoiding the need for surgery. This noninvasive method can be performed without anesthesia, making it more comfortable and convenient for patients. ^{11 12 13 14 15}

Research Team

Mathew D. Sorensen, M.D.

Principal Investigator

University of Washington Medicine

Eligibility Criteria

This trial is for adults with kidney stones larger than 4mm but smaller or equal to 10mm, located in the upper urinary tract and suitable for shock wave treatment. Participants must be able to give informed consent, follow the study protocol, and attend follow-up visits. Excluded are those under 18, pregnant women, patients on anticoagulants who can't stop them temporarily, individuals with certain aneurysms or solitary kidneys, those unable to understand the consent form, anyone with untreated UTIs or urosepsis, prisoners or vulnerable groups.

Inclusion Criteria

The size of the target stone is bigger than 4 millimeters and smaller than or equal to 10 millimeters.

The stone that needs to be treated can be clearly seen and distinguished from other stones.

My kidney stone is suitable for shock wave treatment according to 2016 guidelines.

Exclusion Criteria

I currently have an untreated urinary tract infection or urosepsis.

Your kidney stones cannot be seen clearly on an ultrasound.

I am willing to follow all follow-up care instructions, including getting imaging tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Break Wave Procedure

Participants undergo the Break Wave procedure to fragment urinary tract stones

Telehealth Follow-up

Participants have a telehealth visit to assess initial outcomes

2 weeks post-procedure

1 visit (virtual)

Imaging Follow-up

Participants return for an imaging study to assess stone fragmentation

10 weeks post-procedure

1 visit (in-person)

Extended Follow-up

Participants are monitored for safety and effectiveness, including adverse events and stone status

90 days post-procedure

Treatment Details

Interventions

• Break Wave

Trial Overview The SOUND Pivotal Trial tests the Break Wave™ system's safety and effectiveness in breaking up kidney stones using extracorporeal lithotripsy. Patients will undergo one procedure followed by a telehealth check-in at two weeks and an imaging study around ten weeks later to assess stone fragmentation.

Participant Groups

Group I: Break Wave™ Procedure Experimental Treatment 1 Intervention

The subject will undergo the Break Wave procedure.

Who Is Running the Clinical Trial?

SonoMotion

Lead Sponsor

Trials

2

Recruited

150+

References

1. China pubmed.ncbi.nlm.nih.gov

[Extracorporeal shock wave lithotripsy for renal calculi]. [2006]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Prognostic factors of success of extracorporeal shock wave lithotripsy (ESWL) in the treatment of renal stones. [2022]

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

Extracorporeal shock wave lithotripsy. An update. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Prediction of success rate after extracorporeal shock-wave lithotripsy of renal stones--a multivariate analysis model. [2022]

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

Extracorporeal shock wave lithotripsy: a comprehensive review. [2017]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical analysis of 48-h emergency department visit post outpatient extracorporeal shock wave lithotripsy for urolithiasis. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Acute complications following extracorporeal shock-wave lithotripsy for renal and ureteric calculi. [2008]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

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

10. 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. [2020]

11. Australia pubmed.ncbi.nlm.nih.gov

Lithotripsy for kidney stones. [2005]

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

Impact of shockwave lithotripsy on upper urinary tract calculi. [2019]

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

Extracorporeal shock-wave lithotripsy. [2004]

14. India pubmed.ncbi.nlm.nih.gov

Extracorporeal shockwave lithotripsy without radiation: Ultrasound localization is as effective as fluoroscopy. [2020]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Painless extracorporeal shock wave lithotripsy for outpatients: a new option. [2019]