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Ultrasound to Facilitate Stone Passage
RecruitingHealthy volunteers welcome
Ultrasound Technology to Fragment and Reposition Urinary Stones
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Individuals presenting with at least one kidney stone * Stone with maximum dimension \> 2 mm and ≤ 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.
About the study
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.
What is being tested
- Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) (device)
Sponsor: University of Washington · Participants: 140 · Started: Apr 1, 2023
Contact the study team
- Michael Bailey, PhD · Phone: 206-619-2035
Official record on ClinicalTrials.gov — NCT04796792
Locations in the U.S.
| Washington | University of Washington, Seattle VA Puget Sound Health Care System, Seattle |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.