An interventional study of Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP) in Urinary Stone and Urinary Calculi, sponsored by University of Washington. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
Subjects will be included across three phases:
This study has completed Phase 1. The study is currently recruiting for Phase 2b. Recruitment has not yet started for Phase 2a.
Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's planned enrollment of 140 is above the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention.
Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention.
Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
RCT phase of the trial to demonstrate superiority. All subjects are the concurrent Control to the Phase 2a Treatment group. Subjects receive no intervention.
Feasbility study of the investigational intervention in subjects with spinal cord injury.
Device: 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.
Safety - incidence of return healthcare visits.
Incidence of return health care visits associated with the device or procedure.
Time frame: Day of procedure to 14 months post-procedure
Effectiveness - stone comminution into fragments 2 mm or less.
Number of cases where the largest dimension of any residual stone in the study kidney is less than or equal to 2 mm.
Time frame: Day of procedure to 4 months posts procedure
Safety - incidence of adverse events (AEs)
The incidence of all adverse events (AEs) associated with the device or procedure
Time frame: Day of procedure to 4 months posts procedure
Effectiveness - % residual stone volume
Residual stone volume relative to the initial stone volume
Time frame: Day of procedure to 4 months posts procedure
Effectiveness - need for further stone management
Incidence of new healthcare visits for further stone management
Time frame: Day of procedure to 4 months posts procedure
Effectiveness - Outcome from Wisconsin Stone Quality of Life questionnaire
Quality of life, evaluated by the comparison of Wisconsin Stone Quality of Life (WISQOL) questionnaire scores before and after the investigational procedure. The questionnaire consists of a series of questions to evaluate the symptomatic and functional impact of the stones on a scale of 1 to 5, where a lower score indicates a greater impact. https://urology.wisc.edu/research/wisqol/.
Time frame: Day of procedure to 14 months posts procedure
Not enrolling at this site.
Plan to share: No
Started Apr 2023 (actual). Primary completion is estimated for May 2028, 61 months after the start.
Of 31 interventional studies with no phase under Urinary Calculi, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 61 months is below that.
How these figures are worked out, and which studies are left out of them.
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