Extracorporeal Lithotripsy for Kidney Stones

(SOUND Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure called Break Wave™ (a type of extracorporeal lithotripsy) to determine its safety and effectiveness in breaking up kidney stones in the upper urinary tract. The goal is to assess whether this method can help eliminate stones between 4 mm and 10 mm in size. Candidates for shock wave treatment with kidney stones visible on imaging might be suitable participants. The trial involves the procedure, a follow-up telehealth visit, and an imaging study a few weeks later to evaluate results. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance kidney stone treatment options.

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 prior data suggests that the Break Wave™ system is safe for treating kidney stones?

Research has shown that the Break Wave™ system is generally safe for breaking kidney stones. Studies found that during testing, patients did not experience serious side effects such as internal bleeding, irregular heartbeats, or infections. This indicates that the procedure is usually well-tolerated. Additionally, extracorporeal shock wave lithotripsy (ESWL), a similar method, accurately targets kidney stones without harming nearby organs or tissues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Break Wave is unique because it uses extracorporeal lithotripsy, a non-invasive method, to break down kidney stones from outside the body. Unlike traditional treatments, like surgery or ureteroscopy, which are more invasive, Break Wave offers a potentially safer and more comfortable option. Researchers are excited about this approach because it targets stones precisely without needing incisions, reducing recovery time and minimizing the risk of complications.

What evidence suggests that the Break Wave™ system is effective for kidney stones?

Research has shown that the Break Wave™ system, which participants in this trial will undergo, effectively breaks down kidney stones. In studies, 92% of patients experienced their stones breaking into smaller pieces. Additionally, 75% of patients had these pieces reduced to 4 mm or smaller, facilitating natural passage. These results suggest that the Break Wave™ procedure could be a promising option for treating kidney stones. Overall, the evidence supports its effectiveness in breaking down stones, an important step in treating the condition. ^{2 5 6 7 8}

Who Is on the Research Team?

Mathew D. Sorensen, M.D.

Principal Investigator

University of Washington Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39254129/

Break Wave Lithotripsy for Urolithiasis: Results of the First- ... After determining optimal therapy settings, 36 patients were treated and the effectiveness improved exhibiting fragmentation in 92% (33/36), ...

2. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004091

Break Wave Lithotripsy for Urolithiasis: Results of the First- ... After determining optimal therapy settings, 36 patients were treated and the effectiveness improved exhibiting fragmentation in 92% (33/36), ...

3. urologytimes.com urologytimes.com/view/data-suggest-break-wave-lithotripsy-is-safe-effective-for-urolithiasis

Data suggest Break Wave lithotripsy is safe, effective for ... Among those patients, 92% achieved any stone fragmentation. Additionally, 75% of patients had stone fragments of 4 mm or smaller, and 58% of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03811171

Study Details | NCT03811171 | Break Wave(TM) ... Primary Effectiveness Outcome - Stone Fragmentation, Stone fragmentation as determined by stone passage or imaging confirmation. 12 weeks post-treatment.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0302283825000612

Updated Systematic Review and Meta-analysis of ... This updated systematic review and meta-analysis confirm previous findings suggesting that PCNL achieves the highest stone-free rates, followed by FURS, with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2900184/

The Acute and Long-Term Adverse Effects of Shock Wave ... It is clear that lithotripter SW's have the potential to cause tissue damage and that acute injury can lead to chronic adverse effects. Still, lithotripsy is ...

7. fda.gov fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/content-premarket-notifications-510ks-extracorporeal-shock-wave-lithotripters-indicated

510(k)s for Extracorporeal Shock Wave Lithotripters ... An SWL system focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi (ie, kidney and ureteral stones).

8. hopkinsmedicine.org hopkinsmedicine.org/health/conditions-and-diseases/kidney-stones/extracorporeal-shock-wave-lithotripsy-eswl

Extracorporeal Shock Wave Lithotripsy (ESWL) ESWL is generally considered safe. The shock waves target the stones with precision and typically do not damage surrounding organs and tissues. However, some ...