1. Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial
- Author
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Chew, Ben H, Harper, Jonathan D, Sur, Roger L, Chi, Thomas, De, Shubha, Buckley, Anne R, Paterson, Ryan F, Wong, Victor KF, Forbes, Connor M, Hall, M Kennedy, Kessler, Ross, Bechis, Seth K, Woo, Jason R, Wang, Ralph C, Bayne, David B, Bochinski, Derek, Schuler, Trevor D, Wollin, Tim A, Samji, Rahim, and Sorensen, Mathew D
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,Urologic Diseases ,Clinical Trials and Supportive Activities ,Kidney Disease ,Women's Health ,Patient Safety ,Health Disparities ,Renal and urogenital ,Humans ,Lithotripsy ,Prospective Studies ,Male ,Female ,Middle Aged ,Adult ,Ureteral Calculi ,Aged ,Treatment Outcome ,Urolithiasis ,Kidney Calculi ,urolithiasis ,lithotripsy ,calculi ,ultrasound - Abstract
PurposeThis 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 methodsPatients 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.ResultsForty-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.ConclusionsBWL offered safe and effective noninvasive stone therapy requiring little to no anesthesia and was carried out successfully in nonoperative environments.Trial registrationClinicalTrials.gov identifier: NCT03811171.
- Published
- 2024