NCT03811171 · SonoMotion
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
What this study is about
This is a forward-looking, where both patients and doctors know the treatment given, multi-center, single-treatment group$1 (non-randomly assigned) 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Individuals presenting with at least one kidney stone apparent on CT.
- Stones must be within the upper urinary tract.
- Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
- Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).
Exclusion criteria
- Acute untreated urinary tract infection or urosepsis.
- Uncorrected bleeding disorders or coagulopathies.
- Uncorrected obstruction distal to the stone.
- Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
- Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
- Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
- Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
- Individuals under 18 years of age.
- Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
- Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
- Solitary kidney
- Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
Where
- San Diego, California
- San Francisco, California
- Seattle, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2025 · Source of record for eligibility and locations