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Ultrasound to Facilitate Stone Passage

University of Washington · with Indiana University, VA Puget Sound Health Care System · NCT04796792

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
140
US sites recruiting
2
Study start
April 1, 2023
Record last updated
December 9, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)

Conditions: Urinary Stone; Urinary Calculi

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • VA Puget Sound Health Care System

    Seattle, WA 98108

    Site contact: Branda Levchak · branda.levchak@va.gov

  • University of Washington

    Seattle, WA 98195

    Site contact: Michael Bailey, PhD · 206-619-2035 · mbailey@uw.edu

Study contacts (from the official record)

  • Michael Bailey, PhD · 206-619-2035 · mbailey@uw.edu
  • Barbrina Dunmire, MS · mrbean@uw.edu
All healthy volunteers studies in Washington →
Ultrasound to Facilitate Stone Passage (NCT04796792) | Bored Studies