An interventional study of Burst Wave Lithotripsy in Renal Calculi and Ureteral Calculi, sponsored by University of Washington. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
Burst Wave Lithotripsy (BWL) is a novel method of urinary stone fragmentation that uses 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. This is a single-arm feasibility study to test the ability of BWL to comminute (fragment) stones in humans.
This is a two-center, single-arm, feasibility study. The two centers are located within the US and include: University of Washington (UW) School of Medicine and Indiana University (IU) Health Urology Clinic.
The investigative study will be performed in the operating room prior to a standard-of-care (SoC) ureteroscopic (URS) laser lithotripsy procedure. The subject will already be under anesthesia. Stones will be limited to ≤ 12 mm.
The study has one (treatment) arm and is approved to enroll up to 40 subjects (with the intent to treat 20 subjects). All subjects will be treated with the same output parameters for up to a maximum of 10 minutes per stone. The output parameters are nominally defined as:
A maximum of 3 stones can be treated per subject.
Safety will be monitored by visual observation of the tissue with an ureteroscopic camera, the self-reported occurrences of adverse events, and occurrences of unplanned emergency department or clinic visits. Fragmentation will be measured by visual observation with an ureteroscopic camera and direct measure of stones removed by basket after the procedure.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 40 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney 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.
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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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.
Device: Burst Wave Lithotripsy
Fragment upper urinary tract stones
Safety - Area of Tissue Injury
The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.
Time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Effectiveness - Volume of Fragments < 2 mm
The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume.
Time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Safety - Adverse Event Assessment
The secondary safety outcome is the documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events typically associated with shock wave lithotripsy (SWL) and URS
Time frame: out to 120 days post-procedure
Effectiveness - Time to Full Comminution
projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm
Time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Plan to share: No
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