Renal CalculiNCT03811171
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
A study testing Break Wave extracorporeal lithotripsy in people with Renal Calculi and Urinary Calculi, run by SonoMotion at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi, Urinary Calculi
- 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
- 70 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 20 Aug 2019to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individuals presenting with at least one kidney stone apparent on CT.
- Stones must be within the upper urinary tract.
- Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
- Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).
Who cannot join
- Acute untreated urinary tract infection or urosepsis.
- Uncorrected bleeding disorders or coagulopathies.
- Pregnancy.
- Uncorrected obstruction distal to the stone.
- Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
- Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
Show all 13Show fewer
- Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
- Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
- Individuals under 18 years of age.
- Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
- Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
- Solitary kidney
- Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States3 sites
- Completed
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
Canada3 sites, 2 recruiting
- Completed
University of Alberta, Division of Urology
Edmonton, Alberta, T6G1Z1
- Not yet recruiting
St. Michael's Unity Health Toronto
Toronto, Ontario, M5C 2T2
Kenneth Pace, MD, 416-867-3695, Kenneth.Pace@unityhealth.to
Daniela Ghiculete, MSc, 416-864-6060, Daniela.Ghiculete@unityhealth.to
- Recruiting
Vancouver General Hospital Stone Centre
Vancouver, British Columbia, BC V5Z 1M9
Ben Chew
About this study
Official title: A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones
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
- Renal Calculi, Urinary Calculi
- Being tested
- Break Wave extracorporeal lithotripsy
- Keywords
- Stone, Lithotripsy, Calculi
- Medical subject headings
- Kidney Calculi, Urinary Calculi, 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 85 mm aperture diameter therapy probe driven by a high voltage generator. The therapy probe has a cavity in the middle to accommodate coaxial alignment of an ultrasound imaging probe for treatment guidance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The arm receives the investigational 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 Outcome - Stone Fragmentation
Stone fragmentation as determined by stone passage or imaging confirmation.
Measured: 12 weeks post-treatment
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.
Measured: 12 weeks post-treatment
Secondary outcomes (3)
Secondary effectiveness outcome - Stone Free Status
Radiographic evidence (CT imaging) of stone free status.
Measured: 12 weeks post-treatment
Secondary effectiveness outcome - Residual fragment size
Presence of only stone fragments small enough to pass (less than or equal to 4 mm).
Measured: 12 weeks post-treatment
Secondary safety outcome - Adverse events
documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events associated with shock wave lithotripsy (SWL)
Measured: 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start20 Aug 2019
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Renal CalculiStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SonoMotion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811171
- Sponsor's protocol ID
- CLP-0001
- Other IDs
- R44DK109779
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2019
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Maxwell AD, Cunitz BW, Kreider W, Sapozhnikov OA, Hsi RS, Harper JD, Bailey MR, Sorensen MD. Fragmentation of urinary calculi in vitro by burst wave lithotripsy. J Urol. 2015 Jan;193(1):338-44. doi: 10.1016/j.juro.2014.08.009. Epub 2014 Aug 9.
PubMed 25111910Maxwell AD, MacConaghy B, Bailey MR, Sapozhnikov OA. An investigation of elastic waves producing stone fracture in burst wave lithotripsy. J Acoust Soc Am. 2020 Mar;147(3):1607. doi: 10.1121/10.0000847.
PubMed 32237849Sapozhnikov OA, Maxwell AD, Bailey MR. Modeling of photoelastic imaging of mechanical stresses in transparent solids mimicking kidney stones. J Acoust Soc Am. 2020 Jun;147(6):3819. doi: 10.1121/10.0001386.
PubMed 32611160Harper JD, Lingeman JE, Sweet RM, Metzler IS, Sunaryo PL, Williams JC Jr, Maxwell AD, Thiel J, Cunitz BW, Dunmire B, Bailey MR, Sorensen MD. Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans. J Urol. 2022 May;207(5):1067-1076. doi: 10.1097/JU.0000000000002446. Epub 2022 Mar 21.
PubMed 35311351Chew 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 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones
- ClinicalTrials.gov ID
- NCT03811171
- Acronym / sponsor ID
- CLP-0001
- Conditions
- Renal Calculi, Urinary Calculi
- Keywords
- Stone, Lithotripsy, Calculi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- SonoMotionIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 22 Jan 2019 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Break Wave extracorporeal lithotripsyThe arm receives the investigational 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 (4 listed)
- Individuals presenting with at least one kidney stone apparent on CT.
- Stones must be within the upper urinary tract.
- Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
- Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).
Key exclusion criteria (13 listed)
- Acute untreated urinary tract infection or urosepsis.
- Uncorrected bleeding disorders or coagulopathies.
- Pregnancy.
- Uncorrected obstruction distal to the stone.
- Patients receiving anticoagulants and who are 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 85 mm aperture diameter therapy probe driven by a high voltage generator. The therapy probe has a cavity in the middle to accommodate coaxial alignment of an ultrasound imaging probe for treatment guidance. | Device | Treatment |
Primary outcome
Primary Effectiveness Outcome - Stone Fragmentation
Time frame: 12 weeks post-treatment
Stone fragmentation as determined by stone passage or imaging confirmation.
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
Time frame: 12 weeks post-treatment
The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.
3 secondary outcomes
Secondary effectiveness outcome - Stone Free Status
Time frame: 12 weeks post-treatment
Secondary effectiveness outcome - Residual fragment size
Time frame: 12 weeks post-treatment
Secondary safety outcome - Adverse events
Time frame: 12 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Background: PubMed 25111910Maxwell AD, Cunitz BW, Kreider W, Sapozhnikov OA, Hsi RS, Harper JD, Bailey MR, Sorensen MD. Fragmentation of urinary calculi in vitro by burst wave lithotripsy. J Urol. 2015 Jan;193(1):338-44. doi: 10.1016/j.juro.2014.08.009. Epub 2014 Aug 9.
- Background: PubMed 32237849Maxwell AD, MacConaghy B, Bailey MR, Sapozhnikov OA. An investigation of elastic waves producing stone fracture in burst wave lithotripsy. J Acoust Soc Am. 2020 Mar;147(3):1607. doi: 10.1121/10.0000847.
- Background: PubMed 32611160Sapozhnikov OA, Maxwell AD, Bailey MR. Modeling of photoelastic imaging of mechanical stresses in transparent solids mimicking kidney stones. J Acoust Soc Am. 2020 Jun;147(6):3819. doi: 10.1121/10.0001386.
- Background: PubMed 35311351Harper JD, Lingeman JE, Sweet RM, Metzler IS, Sunaryo PL, Williams JC Jr, Maxwell AD, Thiel J, Cunitz BW, Dunmire B, Bailey MR, Sorensen MD. Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans. J Urol. 2022 May;207(5):1067-1076. doi: 10.1097/JU.0000000000002446. Epub 2022 Mar 21.
- Results publication: 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.
- Sponsor WebsiteLink provided by the sponsor.
- 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.
6 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 Renal Calculi and Urinary Calculi, run by SonoMotion at 6 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oren Levy, PhD (4156722631, oren.levy@sonomotion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Outcome - Stone Fragmentation (time frame: 12 weeks post-treatment). 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 NCT03811171, which also lists 5 linked publications.
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 29 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.