Pivotal trial of Break Wave System for stone disease reaches enrollment goal

The target enrollment has been met in the pivotal SOUND trial (NCT05701098), evaluating the safety and effectiveness of the Break Wave System in fragmenting stones in the kidney or ureter, Sonomotion announced in a news release.¹

James R. Johannes, MD

According to the company, the Break Wave procedure is “designed to fragment kidney stones using low pressure ultrasound waves in fully awake patients, without anesthesia, in the office or clinic.”

Data from the SOUND trial are intended to support submission for FDA 510(k) clearance of the Break Wave device, the company reported. Sonomotion’s initial solution, Stone Clear, was granted 510(k) de novo clearance by the FDA in October 2024 for the clearance of residual fragments following lithotripsy.²

"Patients with obstructive kidney stones typically require treatment in a surgical suite under conscious sedation or general anesthesia," explained James R. Johannes, MD, director at the center of endourology and stone disease at Lehigh Valley Health Network in Pennsylvania, in the news release.¹ "The Break Wave device provides patients with a noninvasive, anesthesia-free treatment option that can be performed at a variety of health care settings. Break Wave has the potential to provide expedited stone treatment and faster convalescence, allowing patients to return to their lives sooner than with traditional treatments."

In total, the prospective, open-label, multicenter SOUND study enrolled 64 adult patients across clinical trial sites in the US and Canada.³ To be eligible for enrollment, patients needed to have at least 1 stone in the upper urinary tract on radiographic imaging. The stone needed to be individually visualized from other stones, indicated for shock wave lithotripsy per American Urological Association 2016 guidelines, and between 4 mm and 10 mm in size.

Patients were excluded from the study if they had acute urinary tract infection or urosepsis, an uncorrected bleeding disorder or coagulation abnormality, a urinary tract obstruction distal to the stone, a calcified abdominal aortic aneurysm or calcified renal artery aneurysms, a solitary kidney, or a comorbidity risk.

Those enrolled in the study will undergo the Break Wave procedure, have a telehealth visit at 2 weeks post-procedure, and then return for an imaging assessment at approximately 10 weeks post-procedure.

The primary efficacy end point is the proportion of patients achieving stone free status or stone fragments of 4 mm or smaller on radiographic assessment at 10-week follow-up. The primary safety end point is the occurrence of device- and procedure-related adverse events. Specifically, the investigators will assess the occurrence of clinically significant or symptomatic hematoma, urinary tract sepsis, and serious cardiac arrythmia through 90 days post-procedure.

The investigators also plan to assess unplanned emergency department or clinic visits and the need for further intervention.

In the news release on the completed enrollment, Sonomotion also reported that they were awarded a $2.2M Fastrack NIH SBIR grant to fund the development of the Break Wave platform.

"We are excited to receive the Fastrack SBIR grant from the NIH. This is a testament to our mission to fundamentally change how kidney stones are treated,” said Oren Levy, PhD, co-founder and CEO of SonoMotion, in the news release.¹ "SonoMotion's platform has the potential to be a first-line treatment for kidney stones, offering a solution for patients who want to avoid anesthesia, without the wait time or cost associated with a surgical suite. Thank you to our investigators and research teams for helping us complete enrollment in our pivotal trial."

REFERENCES

1. Sonomotion completes enrollment in pivotal clinical trial for Break Wave System and secures $2.2 million NIH grant. News release. SonoMotion, Inc. Published online and accessed April 24, 2025. https://www.prnewswire.com/news-releases/sonomotion-completes-enrollment-in-pivotal-clinical-trial-for-break-wave-system-and-secures-2-2-million-nih-grant-302436634.html

2. Sonomotion announces FDA de novo clearance for its Stone Clear Device. News release. Sonomotion, Inc. November 13, 2024. Accessed April 24, 2025. https://www.prnewswire.com/news-releases/sonomotion-announces-fda-de-novo-clearance-for-its-stone-clear-device-302303764.html

3. SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) (SOUND). ClinicalTrials.gov. Last updated February 28, 2024. Accessed April 24, 2025. https://clinicaltrials.gov/study/NCT05701098