破波碎石术治疗泌尿系结石:首次人体国际多机构临床试验结果。

Ben H Chew,Jonathan D Harper,Roger L Sur,Thomas Chi,Shubha De,Anne R Buckley,Ryan F Paterson,Victor K F Wong,Connor M Forbes,M Kennedy Hall,Ross Kessler,Seth K Bechis,Jason R Woo,Ralph C Wang,David B Bayne,Derek Bochinski,Trevor D Schuler,Tim A Wollin,Rahim Samji,Mathew D Sorensen
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引用次数: 0

摘要

本研究报告了一项前瞻性、多中心、单臂临床试验,利用 SonoMotion 公司(加利福尼亚州圣马特奥市)的碎石波碎石(BWL)设备碎除尿路结石。与受试者取得联系,并在治疗后 7、14 和 35 天进行结果评估,术后 70 ± 14 天进行临床随访和 CT 成像检查。主要目的是评估 BWL 的安全性(血肿、并发症等)和有效性(任何碎石、残留碎石≤4 毫米或≤2 毫米、完全无石率),通过肾脏、输尿管和膀胱的非对比 CT 进行评估。88%的病例出现结石碎裂;70%的病例碎石小于4毫米,51%的病例碎石小于2毫米,49%的病例在CT检查中完全无结石;无严重不良事件报告。86%的患者完全没有接受镇痛药物治疗(50%)或接受轻微镇痛(36%)。在确定了最佳治疗方案后,36 名患者接受了治疗,治疗效果有所改善,92% 的患者(33/36)碎石,75% 的患者残留碎石小于 4 毫米,58% 的患者碎石小于 2 毫米,58% 的患者完全无结石。结论BWL提供了安全有效的无创结石治疗,几乎不需要麻醉,并能在非手术环境中成功实施:NCT03811171。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial.
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.
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