Extracorporeal Lithotripsy for Kidney Stones

Recruiting at 1 trial location

Overseen By Oren Levy, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SonoMotion

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Bleeding disorders, 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

70 Participants Needed

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 the Break Wave procedure (a type of extracorporeal lithotripsy). The goal is to determine the safety and effectiveness of this non-surgical approach for clearing kidney stones. Individuals with kidney stones visible on a CT scan, measuring 10 mm or less in the lower kidney or 20 mm or less elsewhere, may be suitable candidates. The trial monitors safety by tracking any complications and the need for additional treatment, and it assesses effectiveness by observing if stones pass naturally after the procedure. As an unphased trial, this study provides patients the chance to explore a potentially groundbreaking non-surgical treatment for kidney stones.

Will I have to stop taking my current medications?

If you are taking blood thinners (anticoagulants), you will need to stop them for the procedure. For other medications, the trial protocol does not specify, so it's best to discuss with the trial team.

What prior data suggests that the Break Wave technology is safe for breaking kidney stones?

Studies have shown that Extracorporeal Shock Wave Lithotripsy (ESWL), similar to the Break Wave technology being tested, is generally safe. This method uses shock waves to break kidney stones into smaller pieces. The procedure targets the stones accurately, usually avoiding harm to nearby organs and tissues.

Research indicates that ESWL has a low rate of serious side effects, meaning they are uncommon. However, some tissue damage may still occur. Most people handle the procedure well, and it is considered quick and simple.

While researchers continue to test the specific Break Wave technology in this trial, findings from similar treatments suggest it might also be safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Break Wave Extracorporeal Lithotripsy because it offers a non-invasive way to treat kidney stones using sound waves. Unlike traditional methods like surgery or invasive procedures that require anesthesia, this technique focuses on breaking down stones from outside the body, potentially reducing recovery time and hospital stays. Additionally, the precision of the sound waves targets only the stones, minimizing damage to surrounding tissues and making it a promising alternative for patients who can't undergo surgery.

What evidence suggests that the Break Wave technology is effective for breaking kidney stones?

Studies have shown that Break Wave Extracorporeal Lithotripsy, the investigational treatment in this trial, effectively treats kidney stones. In one study, 92% of patients experienced their kidney stones breaking into smaller pieces. Additionally, 75% of these patients had stone fragments measuring 4 mm or smaller. This indicates the treatment effectively breaks down stones for easier passage from the body. The procedure is also considered safe, with few reported complications. These findings make Break Wave a promising option for those dealing with stubborn kidney stones. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with kidney stones visible on CT scans, located in the upper urinary tract and fitting within specific size guidelines (≤10 mm for lower pole stones, ≤20 mm for others). It's not suitable for those with certain health risks, untreated infections, bleeding disorders, pregnancy, or if they can't stop blood thinners. Vulnerable individuals and minors are also excluded.

Inclusion Criteria

The stones must be located in the upper part of the urinary system.

Your kidney stones can be treated with shock wave lithotripsy according to the American Urology Association (AUA) 2016 guidelines.

Your kidney stones need to be a certain size, as measured by a CT scan, to be eligible for the study.

Exclusion Criteria

Your body's shape or position makes it hard to use the Break Wave pulse treatment.

You have other health conditions that may make it risky for you to have the Break Wave procedure, such as unusual body structures that could make it hard for the stone pieces to pass through.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Break Wave procedure for urinary tract stone fragmentation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and stone passage

12 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Break Wave Extracorporeal Lithotripsy

Trial Overview The study tests the Break Wave extracorporeal lithotripsy technology's safety and effectiveness in breaking up kidney stones without surgery. Up to 30 participants will undergo this procedure under various anesthesia levels at a hospital or clinic setting.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

The arm receives the investigational Break Wave procedure.

Who Is Running the Clinical Trial?

SonoMotion

Lead Sponsor

Trials

2

Recruited

150+

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.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), ...

2. 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 ...

3. 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 ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK560887/

Extracorporeal Shockwave Lithotripsy - StatPearls - NCBI - NIH Extracorporeal shockwave lithotripsy (ESWL) is a pioneering, noninvasive approach to managing urinary calculi, revolutionizing the landscape of urological care.

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 ... Children: The safety and effectiveness of this device in the treatment of urolithiasis in children have not been demonstrated. Although children have been ...

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 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9584717/

The Clinical Efficacy and Safety of Extracorporeal Shock ... ESWL is effective in treating patients with urinary calculi with a simple, safe, and quick operation and a low incidence of adverse events.