National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
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.
