Kidney StoneSOUNDNCT05701098
SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
A study testing Break Wave extracorporeal lithotripsy in people with Kidney Stone and Urolithiasis, run by SonoMotion at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Urolithiasis, Nephrolithiasis
- What is being tested?
- Break Wave extracorporeal lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 9 Oct 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects presenting with at least one stone apparent on radiographic imaging.
- Target stone must be within the upper urinary tract.
- Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines.
- Target stone size is > 4 mm and ≤ 10 mm.
- Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits.
- Target stone can be individually visualized from other stones.
Who cannot join
- Subject has an acute untreated urinary tract infection or urosepsis.
- Subject has an uncorrected bleeding disorder or coagulation abnormality.
- Subject is confirmed to be or suspected to be pregnant.
- Subject has a urinary tract obstruction distal to the stone.
- Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
- Subject has stones that are not echogenically visible with ultrasound.
Show all 14Show fewer
- Subject belongs to a vulnerable group (prisoner, etc.).
- Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
- Subject is under 18 years of age.
- Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
- Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
- Subject has a solitary kidney.
- Subject has a comorbidity risk(s) which, at the discretion of the physician, would make the subject a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
- Subject is unable to read or comprehend the consent form.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Northwestern Medicine
Chicago, Illinois, 60611
Vanderbilt University
Nashville, Tennessee, 37232
University of California- San Diego
San Diego, California, 92037
University of California - San Francisco
San Francisco, California, 94143
Kaiser Permanente
Santa Clara, California, 95051
University of Washington
Seattle, Washington, 98195
Canada3 sites
University of Alberta
Edmonton, Alberta, T6G 1Z1
St. Michael's Hospital, University of Toronto
Toronto, Ontario, M5C 2T2
University of British Columbia
Vancouver, British Columbia
About this study
Official title: Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones
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.
Read the detailed description
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to demonstrate the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave™ technology. Up to 116 patients will be screened to participate. Depending on the institution, the procedure may be performed in an outpatient hospital surgical environment, or in a non-surgical environment such as a clinic or office procedure room. Subjects will have a target stone diagnosed to be >4millimeter (mm) to 10 mm in size.
Safety will be measured by the adverse event occurrence, unplanned emergency department or clinic visits, and the need for further intervention. Effectiveness will be determined by the size of fragments identified at the 10 week follow-up imaging.
- Conditions
- Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith
- Being tested
- Break Wave extracorporeal lithotripsy
- Keywords
- Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith, Urinary Calculi, Ultrasound therapy, Non-invasive, Extracorporeal
- Medical subject headings
- Kidney Calculi, Urolithiasis, Nephrolithiasis, Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Break Wave extracorporeal lithotripsyDevice
The Break Wave device will be used to exert a low amplitude burst of ultrasound waves focused at the kidney stone. The primary components of the device include an ultrasound imaging system and a therapy probe driven by a high voltage generator. The probe will be placed on the patient's skin, the stone located via diagnostic ultrasound and up to 30 minutes of therapy will be delivered to the stone. The therapy probe accommodates coaxial alignment of an ultrasound imaging probe for treatment guidance.
| Study group | Role | What they receive |
|---|---|---|
| Break Wave™ Procedure | Experimental | The subject will undergo the Break Wave procedure. Receives: Device: Break Wave extracorporeal lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Proportion of subjects with a radiographic assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (≤ 4 mm).
Measured: 10 +/- 2 weeks post final Break Wave procedure
Primary Safety Endpoint
Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia
Measured: During procedure and through 90 days post-procedure
Secondary outcomes (1)
Secondary safety endpoint
Occurrence of all device and procedure related adverse events (AEs), including serious adverse events (SAEs), and Unanticipated Adverse Device Effects (UADEs)
Measured: During procedure and through 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start9 Oct 2023
- Primary completion18 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- SonoMotion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701098
- Sponsor's protocol ID
- CP0002
- Acronym
- SOUND
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chew BH, Harper JD, Sur RL, Chi T, De S, Buckley AR, Paterson RF, Wong VKF, Forbes CM, Hall MK, Kessler R, Bechis SK, Woo JR, Wang RC, Bayne DB, Bochinski D, Schuler TD, Wollin TA, Samji R, Sorensen MD. Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial. J Urol. 2024 Oct;212(4):580-589. doi: 10.1097/JU.0000000000004091. Epub 2024 Sep 10.
PubMed 39254129
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones
- ClinicalTrials.gov ID
- NCT05701098
- Acronym / sponsor ID
- SOUND / CP0002
- Conditions
- Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith
- Keywords
- Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith, Urinary Calculi, Ultrasound therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- SonoMotionIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to demonstrate the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave™ technology. Up to 116 patients will be screened to participate. Depending on the institution, the procedure may be performed in an outpatient hospital surgical environment, or in a non-surgical environment such as a clinic or office procedure room. Subjects will have a target stone diagnosed to be >4millimeter (mm) to 10 mm in size.
Safety will be measured by the adverse event occurrence, unplanned emergency department or clinic visits, and the need for further intervention. Effectiveness will be determined by the size of fragments identified at the 10 week follow-up imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Break Wave™ Procedure | Experimental | Device: Break Wave extracorporeal lithotripsyThe subject will undergo the Break Wave procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects presenting with at least one stone apparent on radiographic imaging.
- Target stone must be within the upper urinary tract.
- Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines.
- Target stone size is > 4 mm and ≤ 10 mm.
- Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits.
Key exclusion criteria (14 listed)
- Subject has an acute untreated urinary tract infection or urosepsis.
- Subject has an uncorrected bleeding disorder or coagulation abnormality.
- Subject is confirmed to be or suspected to be pregnant.
- Subject has a urinary tract obstruction distal to the stone.
- Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Break Wave extracorporeal lithotripsyThe Break Wave device will be used to exert a low amplitude burst of ultrasound waves focused at the kidney stone. The primary components of the device include an ultrasound imaging system and a therapy probe driven by a high voltage generator. The probe will be placed on the patient's skin, the stone located via diagnostic ultrasound and up to 30 minutes of therapy will be delivered to the stone. The therapy probe accommodates coaxial alignment of an ultrasound imaging probe for treatment guidance. | Device | Break Wave™ Procedure |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 10 +/- 2 weeks post final Break Wave procedure
Proportion of subjects with a radiographic assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (≤ 4 mm).
Primary Safety Endpoint
Time frame: During procedure and through 90 days post-procedure
Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia
1 secondary outcome
Secondary safety endpoint
Time frame: During procedure and through 90 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 39254129Chew BH, Harper JD, Sur RL, Chi T, De S, Buckley AR, Paterson RF, Wong VKF, Forbes CM, Hall MK, Kessler R, Bechis SK, Woo JR, Wang RC, Bayne DB, Bochinski D, Schuler TD, Wollin TA, Samji R, Sorensen MD. Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial. J Urol. 2024 Oct;212(4):580-589. doi: 10.1097/JU.0000000000004091. Epub 2024 Sep 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Break Wave extracorporeal lithotripsy in people with Kidney Stone and Urolithiasis, run by SonoMotion at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 10 +/- 2 weeks post final Break Wave procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.