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.

中文翻译：

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碎石术治疗尿石症：首次人体国际多机构临床试验的结果。


目的 本研究报告了一项前瞻性、多中心、单臂临床试验，该试验利用 SonoMotion（加利福尼亚州圣马特奥）破波碎石 (BWL) 装置碎裂尿路结石。材料和方法 泌尿系结石患者接受 30 分钟的单次治疗，峰值负压为 4.5 至 8 MPa。在治疗后 7、14 和 35 天联系受试者并评估结果，并在术后 70 ± 14 天进行临床随访和 CT 成像。主要目标是通过平扫 CT 肾脏、输尿管、和膀胱。结果 5 个中心对 44 名输尿管结石 (43%) 或肾结石 (57%) 患者进行了治疗。 88% 的病例发生结石碎裂； 70% 的患者碎片≤ 4 毫米，51% 的患者碎片≤ 2 毫米，而 49% 的患者 CT 上完全没有结石；没有报告严重不良事件。 86% 的患者要么根本不接受镇痛药物（50%），要么接受轻微镇痛（36%）。在确定最佳治疗设置后，36 名患者接受了治疗，疗效得到改善，92% (33/36) 的患者出现碎片，75% 的患者残留碎片≤ 4 毫米，58% 的患者碎片≤ 2 毫米，其中 58% 的患者完全没有结石。下极结石患者的有效性较低，其中 81% 为碎石，71% 的碎石≤ 4 毫米，29% 的碎石≤ 2 毫米，29% 的碎石完全无；输尿管远端结石患者中，89% 完全无结石。结论 BWL 提供安全有效的非侵入性结石治疗，几乎不需要麻醉，并且在非手术环境中成功实施。试验注册 临床试验。政府标识符：NCT03811171。