Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Public ClinicalTrials.gov record NCT03811171. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03811171
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 70 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 19, 2019
- Primary completion
- Jan 29, 2027
- Completion
- Mar 29, 2027
- Last update posted
- Jul 28, 2025
2019 – 2027
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego Health | San Diego | California | 92103 | Completed |
| University of California, San Francisco | San Francisco | California | 94143 | Completed |
| University of Washington Medical Center | Seattle | Washington | 98195 | Completed |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03811171, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03811171 live on ClinicalTrials.gov.