RecruitingNot ApplicableNCT03811171

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

A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones

Sponsor

SonoMotion

Enrollment

70 participants

Start Date

Aug 20, 2019

Study Type

INTERVENTIONAL

Conditions

Urinary Calculi Renal calculi

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. 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study of the Break Wave lithotripter — a new device that uses focused sound waves to break up kidney stones without surgery. This approach (called shockwave lithotripsy, or SWL) is already a standard treatment, and this study tests whether the Break Wave device is safe and effective for eligible patients with kidney stones in the upper urinary tract. You may be eligible if: - You are 18 years old or older - You have at least one kidney stone visible on CT scan - Your stone is in the upper urinary tract (kidney or upper ureter) - Your stone meets size guidelines: 10 mm or less in the lower kidney pole, or 20 mm or less elsewhere - Your stone is eligible for shockwave lithotripsy per AUA guidelines You may NOT be eligible if: - You have an active, untreated urinary tract infection or urosepsis - You have a bleeding disorder or are on blood thinners and cannot stop them - You are pregnant - You have a blockage below the stone - You have only one kidney - You have a calcified aortic or renal artery aneurysm - You are under 18 or belong to a vulnerable group (mentally disabled, prisoner) Talk to your urologist about your stone size, location, and whether you need to pause anticoagulant medications before the procedure.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBreak 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.