Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
NCT ID: NCT03811171
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2019-08-20
2027-03-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
The arm receives the investigational Break Wave procedure.
Break Wave extracorporeal lithotripsy
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.
Interventions
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Break Wave extracorporeal lithotripsy
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
SonoMotion
INDUSTRY
Responsible Party
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Locations
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University of California San Diego Health
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Alberta, Division of Urology
Edmonton, Alberta, Canada
Vancouver General Hospital Stone Centre
Vancouver, British Columbia, Canada
St. Michael's Unity Health Toronto
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Ben Chew
Role: primary
References
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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.
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.
Maxwell 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.
Sapozhnikov 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.
Harper 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.
Related Links
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Sponsor Website
Other Identifiers
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CLP-0001
Identifier Type: -
Identifier Source: org_study_id
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