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โ† Trials
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Ultrasound to Facilitate Stone Passage

RecruitingNAAges 18 Years - anyAllUniversity of Washington
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In plain words

What the trial is, and whether it could suit you

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Individuals presenting with at least one kidney stone * Stone with maximum dimension \> 2 mm and โ‰ค 7 mm as determined by clinical imaging * Individuals with SCI - (Phase 2b only) Exclusion Criteria: * Individuals under 18 years of age * Individuals who are pregnant or who are trying to get pregnant * Prisoners * with cognitive impairment that would limit their ability to comprehend their role in consent or participation. * Individuals who are unable to read or understand English * Individuals who are unable or unwilling to participate in follow up activities * Individuals who cannot be positioned for ultrasound imaging * Individuals with uncorrected bleeding disorders or coagulopathies * Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure * Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure * Individuals with a solitary kidney * Individuals with an uncorrected urinary tract obstruction * Individuals with an untreated infection * Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure * Individuals who have received two previous investigational procedures for the same stone target * Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.
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What it tests

  • Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
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Where

3 sites
Indiana University Health - North Hospital
Carmel, United States
VA Puget Sound Health Care System
Seattle, United States
University of Washington
Seattle, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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