Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

Launched by SONOMOTION · Jan 18, 2019

Keywords

ClinConnect Summary

The Break Wave™ Extracorporeal Lithotripter study is looking at a new way to treat kidney stones using a technology called SonoMotion Break Wave. This study aims to find out how safe and effective this method is for breaking up stones located in the upper urinary tract, which includes parts of the kidneys and ureters. The trial will involve up to 30 participants who have kidney stones visible on a CT scan. To be eligible, participants must have stones that meet certain size criteria, meaning they should be no larger than 10 millimeters for stones in the lower part of the kidney and no larger than 20 millimeters for stones in other areas.

Participants in this study can expect to undergo the procedure in a hospital or clinic without needing to stay overnight. The procedure will be performed using different levels of anesthesia, which may range from no anesthesia at all to being fully asleep. Researchers will monitor participants for any side effects and check how well the stones are broken up by comparing CT scans taken before and after the procedure. It’s important to note that certain individuals, such as those with specific health issues or conditions, may not be eligible to participate in this study. Overall, this trial aims to improve treatment options for people suffering from kidney stones.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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).
• Exclusion Criteria:
• • 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.