Extracorporeal Lithotripsy for Kidney Stones

Recruiting at 5 trial locations

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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.

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+