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ACTIVE NOT RECRUITING NA

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.

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

FieldValue
Enrollment Target 116 participants
Start Date 2023-10-09
Est. Completion 2026-01
Phase NA

Sponsor

SonoMotion

2 total trials

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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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial