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Ultrasound to Facilitate Stone Passage

This study is testing new ultrasound technologies, Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP), to help people pass kidney stones without anesthesia. BWL breaks up stones, and UP helps move them. The study is looking for people aged 18 and older with kidney stones between 2mm and 7mm. The main goals are to see how safe the treatment is (checking for return healthcare visits for up to 14 months) and how well it breaks stones into small pieces (2mm or less, checked for up to 4 months). The study has completed its first phase and is currently recruiting for Phase 2b, which includes individuals with spinal cord injury.

Study design
This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 140 participants across different phases, including a randomized controlled trial in Phase 2a.
What's involved
You may receive up to three treatments on distinct stone targets, with each session lasting a maximum of 30 minutes. You might return for additional sessions after at least 21 days.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 14 months after the procedure, and the effectiveness of stone comminution will be checked for up to 4 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04796792

Ultrasound to Facilitate Stone Passage

Recruiting
NAAges 18+InterventionalTreatment
University of Washington
~140 participants
Updated 2025-12-09 on ClinicalTrials.gov
What's tested:Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety - incidence of return healthcare visits.
Measured over Day of procedure to 14 months post-procedure
+1 more outcome measured

Conditions

Urinary Stone
Urinary Calculi

Explore related trials

Urolithiasis

Where it's being run

3 sites across 2 states
Washington2
Indiana1

Study leadership

  • Jonathan Harper, MD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Michael Bailey, PhD
[email protected]
206-619-2035
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety - incidence of return healthcare visits.Day of procedure to 14 months post-procedure

    Incidence of return health care visits associated with the device or procedure.

  • Effectiveness - stone comminution into fragments 2 mm or less.Day of procedure to 4 months posts procedure

    Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.