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Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
NCT03811171 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Break Wave extracorporeal lithotripsy
Study Locations (6)
California
- University of California San Diego Health — San Diego
- University of California, San Francisco — San Francisco
Washington
- University of Washington Medical Center — Seattle
Alberta
- University of Alberta, Division of Urology — Edmonton
British Columbia
- Vancouver General Hospital Stone Centre — Vancouver
Ontario
- St. Michael's Unity Health Toronto — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-08-20 |
| Est. Completion | 2027-03-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03811171
The ClinicalTrials.gov registry entry for NCT03811171 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SonoMotion, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Renal Calculi appearing as the primary indexed condition, and to 1 intervention — of which Break Wave extracorporeal lithotripsy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03811171 reports 6 study locations spanning 5 distinct geographic areas — top geographies include California, Washington, Alberta. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03811171 about?
NCT03811171 is a clinical study titled "Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study". 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 surgic...
What is the current status of trial NCT03811171?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2019-08-20. Estimated completion is 2027-03-30.
What conditions does trial NCT03811171 study?
This clinical trial studies the following conditions: Renal Calculi, Urinary Calculi. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03811171?
The interventions under investigation include: Break Wave extracorporeal lithotripsy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03811171?
This trial is sponsored by SonoMotion, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03811171 being conducted?
This trial has 6 study locations across California, Washington, Alberta, British Columbia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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