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Clinical Trial
. 2024 Oct;212(4):580-589.
doi: 10.1097/JU.0000000000004091. Epub 2024 Sep 10.

Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial

Ben H Chew  1 , Jonathan D Harper  2 , Roger L Sur  3 , Thomas Chi  4 , Shubha De  5 , Anne R Buckley  6 , Ryan F Paterson  1 , Victor K F Wong  1 , Connor M Forbes  1 , M Kennedy Hall  7 , Ross Kessler  7 , Seth K Bechis  3 , Jason R Woo  3 , Ralph C Wang  8 , David B Bayne  4 , Derek Bochinski  5 , Trevor D Schuler  5 , Tim A Wollin  5 , Rahim Samji  5 , Mathew D Sorensen  2
Affiliations
Clinical Trial

Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial

Ben H Chew et al. J Urol. 2024 Oct.

Erratum in

Abstract

Purpose: This study reports on a prospective, multicenter, single-arm, clinical trial utilizing the SonoMotion (San Mateo, California) Break Wave lithotripsy (BWL) device to fragment urinary stones.

Materials and methods: Patients with a urinary stone underwent a single treatment of 30 minutes and peak negative pressure of 4.5 to 8 MPa. Subjects were contacted and outcomes assessed at 7, 14, and 35 days after treatment, with clinical follow-up and CT imaging 70 ± 14 days postprocedure. The primary objectives were to assess the safety (hematomas, complications, etc) and effectiveness of BWL (any fragmentation, residual fragments ≤4 mm or ≤2 mm, and completely stone-free rate) as assessed via noncontrast CT-kidneys, ureters, and bladder.

Results: Forty-four patients with a ureteral (43%) or renal (57%) stone were treated across 5 centers. Stone fragmentation occurred in 88% of cases; 70% had fragments ≤ 4 and 51% ≤ 2 mm, while 49% were completely stone free on CT; no serious adverse events were reported. Eighty-six percent of patients received either no analgesic medication at all (50%) or minor analgesia (36%). After determining optimal therapy settings, 36 patients were treated and the effectiveness improved exhibiting fragmentation in 92% (33/36), residual fragments ≤ 4 mm in 75% and 58% with fragments ≤ 2 mm with 58% completely stone free. Effectiveness was less in subjects with lower pole stones with 81% fragmentation, 71% having fragments ≤ 4 mm, 29% with fragments ≤ 2 mm, and 29% completely stone free; of distal ureteral stone patients, 89% were completely stone free.

Conclusions: BWL offered safe and effective noninvasive stone therapy requiring little to no anesthesia and was carried out successfully in nonoperative environments.

Trial registration: ClinicalTrials.gov identifier: NCT03811171.

Keywords: calculi; lithotripsy; ultrasound; urolithiasis.

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Conflict of interest statement

Conflict of Interest Disclosures: Drs Chew, Sur, and Buckley are members of SonoMotion’s Scientific Advisory Board (SAB) and have received options for their role in the SAB. Dr Sorensen has equity and a consulting agreement with SonoMotion Inc, which licensed the reported technology from the University of Washington for commercialization. The remaining authors declare no personal financial interests from this study.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Break Wave device. A, The imaging probe (left) and therapy probe (right). B, The imaging probe clicks into the center of therapy probe for treatment. C, The therapy probe and foot pedal are plugged into the therapy generator. D, The entire device required for treatment. E, An optional positioning arm may be attached to the clinic bed and used to assist in positioning.
Figure 2.
Figure 2.
Efficacy success rates.
Figure 3.
Figure 3.
Anesthesia usage.
See this image and copyright information in PMC

References

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