Break Wave lithotripsy achieves non-inferiority to shock wave in pivotal trial

Break Wave lithotripsy achieved non-inferiority to shock wave lithotripsy for both efficacy and safety in a multicenter North American pivotal trial—without anesthesia, without an operating room, and in clinic settings for 94% of procedures—supporting FDA clearance in January 2026 and positioning the technology as a potential point-of-care disruptor in urolithiasis management, according to Ben H. Chew, MD, MSc, FRCSC, a study investigator and an endourologist at the University of British Columbia in Vancouver.¹

The SOUND pivotal trial (NCT05701098), which Chew presented at the 2026 American Urological Association Annual Meeting in Washington, DC, enrolled 64 adults with ureteral or renal stones measuring 4 mm to 10 mm across 10 US and Canadian sites. A 30-minute treatment session was delivered entirely outside the operating room without anesthesia or sedation. The primary efficacy end point—stone-free or residual fragments 4 mm or smaller at 10 weeks—was met in 70% of patients overall, with 48% completely stone-free. Distal ureteral and ureterovesical junction stones achieved 90% success, including 72% stone-free. Adverse events (AEs) were predominantly mild and transient; no sepsis, renal hematoma, or arrhythmia occurred over 90 days of follow-up.

"The study was designed to show non-inferiority of Break Wave lithotripsy to shock wave lithotripsy—and we showed that," Chew said, noting that non-inferiority was demonstrated for both effectiveness and AEs. He added that the 90% success rate for distal ureteral stones is consistent with shock wave performance at that location and likely comparable to ureteroscopy based on available literature.

"And we're not even mentioning the fact that this was all under no anesthesia and minimally invasive as well,” Chew added.

The absence of anesthesia has implications that extend well beyond the procedure itself. Chew described the cumulative burden that conventional stone treatments impose—pre-operative clearance, bowel preparation at some centers, anesthesiology support, PACU recovery, and the requirement that patients arrange transportation.

"We've literally had patients come in on their lunch hour, drive themselves here, get the procedure, then drive themselves home," he said. "Patients are in and out within one hour." That experience contrasts sharply with the 2-to-4-hour institutional footprint that often surrounds a 20-minute ureteroscopic procedure.

The device's portability further expands where treatment can be delivered. Break Wave runs on a standard outlet, can be wheeled to any clinical setting, and has been used in emergency department contexts.

"You could do it at someone's house if you needed to," Chew said. He noted that the technology traces its origins to NASA-funded research specifically aimed at enabling stone treatment during long-duration spaceflight—a design constraint that demanded portability, non-invasiveness, and operability without specialist support.

Chew also addressed timing as an underappreciated factor in efficacy. Prolonged stone impaction causes ureteral edema that reduces the effectiveness of shock wave lithotripsy. The ability to treat at the point of first presentation—rather than scheduling a procedure weeks later—may improve outcomes in ways that aggregate trial data do not fully capture.

On patient preference, 97% of treated patients said they would choose Break Wave again, including 92% of those with prior ureteroscopy or shock wave lithotripsy experience. Chew acknowledged that the prior-treatment subgroup was small—approximately 12 to 13 patients—but noted that the directional signal was consistent.

"Patients really don't like having the anesthesia with shock wave and definitely with ureteroscopy," he said. "And it's not just disruptive to yourself—it's disruptive to your friends and family who need to come pick you up."

Reference

1. Chew BH, Harper JD, Ahn J, et al. SOUND pivotal trial of Break Wave lithotripsy for upper urinary tract stones. Presented at: 2026 American Urological Association Annual Meeting; May 15-18, 2026; Washington, DC. https://www.auajournals.org/doi/10.1097/01.JU.0001192572.07890.f8.03