Recruiting

Ultrasound Treatment

Sponsor:

University of Washington

Code:

NCT04796792

Conditions

Urinary Stone

Urinary Calculi

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief summary:

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.

Conditions

Urinary Stone

Urinary Calculi

Study ID

NCT04796792

Start date

Apr 1, 2023

Status verified date

Dec, 2025

Completion date

Oct 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I: Feasibility Treatment group

Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention.

experimental: Phase 2a: Treatment Group of a randomized control trial

RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention.

no intervention: Phase 2a: Control group of a randomized control trial

RCT phase of the trial to demonstrate superiority. All subjects are the concurrent Control to the Phase 2a Treatment group. Subjects receive no intervention.

experimental: Phase 2b: Spinal Cord Injury Feasibility Study

Feasbility study of the investigational intervention in subjects with spinal cord injury.

Interventions

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

Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.

Primary outcome measure

  • Safety - incidence of return healthcare visits. [ Time Frame: Day of procedure to 14 months post-procedure ]
  • Effectiveness - stone comminution into fragments 2 mm or less. [ Time Frame: Day of procedure to 4 months posts procedure ]

Central Contacts and Locations

Central contacts

Michael Bailey, PhD

206-619-2035mbailey@uw.edu

Barbrina Dunmire, MS

mrbean@uw.edu

Locations

VA Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

Branda Levchak

branda.levchak@va.gov

Principal Investigator:

Claire Yang, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Michael Bailey, PhD

206-619-2035mbailey@uw.edu

Barbara Burke

burkeb3@uw.edu

Principal Investigator:

Jonathan Harper, MD

More Information

Sponsor

University of Washington

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-12-09.