Fragmentation of urinary calculi in vitro by burst wave lithotripsy.
Adam D Maxwell, Bryan W Cunitz, Wayne Kreider...
https://pubmed.ncbi.nlm.nih.gov/25111910Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03811171
A Study of the SonoMotion Break Wave System to Break Upper Urinary Tract Stones
Led by SonoMotion · Updated on 2025-07-29
70
Participants Needed
6
Research Sites
8 weeks
Total Duration
On this page
Sponsors
S
SonoMotion
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the SonoMotion Break Wave device to break stones in the upper urinary tract. This prospective, open-label, multi-center, single-arm study will include up to 30 participants with stones sized up to 10 mm in the lower pole and up to 20 mm elsewhere. The study focuses on assessing safety through self-reported adverse events and emergency visits, as well as stone fragmentation measured by stone passage and CT image comparison. Participants will receive the investigational Break Wave procedure, which uses low amplitude ultrasound waves focused on the kidney stone via a specialized therapy probe with an integrated ultrasound imaging probe for guidance. The procedure is performed in hospital surgical environments as outpatient care or in non-surgical settings such as clinics. Anesthesia levels may vary from none to general anesthesia during the procedure. During the study, participants will be monitored for safety outcomes including hematoma, urinary tract infection, or heart rhythm issues over 12 weeks post-treatment. Effectiveness will be evaluated by stone fragmentation, stone free status, and residual fragment size using CT scans and self-reports. Follow-up procedures, including CT scans and adverse event tracking, will assess safety and treatment outcomes throughout the 12-week period after the procedure.
CONDITIONS
Brief Title
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals with at least one kidney stone visible on CT
- Stones located within the upper urinary tract
- Stones indicated for shock wave lithotripsy treatment per AUA 2016 guidelines
- Stone size must be 10 mm or smaller for lower pole stones
- Stone size must be 20 mm or smaller for stones in other locations
You will not qualify if you...
- Acute untreated urinary tract infection or urosepsis
- Uncorrected bleeding disorders or coagulopathies
- Pregnancy
- Uncorrected obstruction below the stone
- Use of anticoagulants unwilling or unable to stop for the procedure
- Stones not visible by ultrasound or not positionable for treatment
- Belonging to vulnerable groups (pregnant, mentally disabled, prisoner, etc.)
- Unwillingness to comply with follow-up including post-procedure CT
- Under 18 years of age
- Anatomical issues preventing proper treatment delivery
- Calcified abdominal aortic or renal artery aneurysms
- Solitary kidney
- Other medical risks making the patient a poor candidate as determined by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Single treatment session
Participants receive the Break Wave extracorporeal lithotripsy procedure, which uses ultrasound waves focused at the kidney stone to break it.
1 visit (in-person)
Follow-up
Duration - 12 weeks post-treatment
Participants are monitored for safety and effectiveness outcomes including stone fragmentation and adverse events after the treatment.
Approximately 3 follow-up visits
Trial Site Locations
Total: 6 locations
1
University of California San Diego Health
San Diego, California, United States, 92103
Completed
2
University of California, San Francisco
San Francisco, California, United States, 94143
Completed
3
University of Washington Medical Center
Seattle, Washington, United States, 98195
Completed
4
University of Alberta, Division of Urology
Edmonton, Alberta, Canada, T6G1Z1
Completed
5
Vancouver General Hospital Stone Centre
Vancouver, British Columbia, Canada, BC V5Z 1M9
Actively Recruiting
6
St. Michael's Unity Health Toronto
Toronto, Ontario, Canada, M5C 2T2
Not Yet Recruiting
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Research Team
O
Oren Levy, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
An investigation of elastic waves producing stone fracture in burst wave lithotripsy.
Adam D Maxwell, Brian MacConaghy, Michael R Bailey...
https://pubmed.ncbi.nlm.nih.gov/32237849Modeling of photoelastic imaging of mechanical stresses in transparent solids mimicking kidney stones.
Oleg A Sapozhnikov, Adam D Maxwell, Michael R Bailey
https://pubmed.ncbi.nlm.nih.gov/32611160Fragmentation of Stones by Burst Wave Lithotripsy in the First 19 Humans.
Jonathan D Harper, James E Lingeman, Robert M Sweet...
https://pubmed.ncbi.nlm.nih.gov/35311351Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial.
Ben H Chew, Jonathan D Harper, Roger L Sur...
https://pubmed.ncbi.nlm.nih.gov/39254129