Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
NCT05701098 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones. Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.
Conditions Studied
Interventions
- DEVICE Break Wave extracorporeal lithotripsy
Study Locations (10)
California
- University of California- San Diego — San Diego
- University of California - San Francisco — San Francisco
- Kaiser Permanente — Santa Clara
Illinois
- Northwestern Medicine — Chicago
Pennsylvania
- Lehigh Valley Health Network — Allentown
Tennessee
- Vanderbilt University — Nashville
Washington
- University of Washington — Seattle
Alberta
- University of Alberta — Edmonton
British Columbia
- University of British Columbia — Vancouver
Ontario
- St. Michael's Hospital, University of Toronto — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2023-10-09 |
| Est. Completion | 2026-01 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05701098
The ClinicalTrials.gov registry entry for NCT05701098 describes a study currently listed as active not 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 116 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 7 conditions, with Kidney Stone 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: NCT05701098 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Illinois, Pennsylvania. 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 NCT05701098 about?
NCT05701098 is a clinical study titled "SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)". The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones. Participants will a) undergo the Break Wave™ procedure, b) have a teleheal...
What is the current status of trial NCT05701098?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 116 participants. The study started on 2023-10-09. Estimated completion is 2026-01.
What conditions does trial NCT05701098 study?
This clinical trial studies the following conditions: Kidney Stone, Nephrolithiasis, Urolithiasis, Kidney Calculi, Renal 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 NCT05701098?
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 NCT05701098?
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 NCT05701098 being conducted?
This trial has 10 study locations across California, Illinois, Pennsylvania, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.