■这项研究报告了一项前瞻性,多中心,单臂,利用SonoMotion(SanMateo,California)BreakWave碎石术(BWL)装置碎片尿路结石。
■尿路结石患者接受30分钟的单次治疗,峰值负压为4.5至8MPa。在治疗后第7、14和35天接触受试者并评估结果,术后70±14天进行临床随访和CT成像。主要目标是评估安全性(血肿,并发症,等)和BWL的有效性(任何碎片,残余碎片≤4mm或≤2mm,和完全无结石率)通过非对比CT肾脏评估,输尿管,和膀胱。
■在5个中心治疗了44例输尿管(43%)或肾脏(57%)结石患者。88%的病例发生碎石;70%的碎片≤4,51%≤2毫米,而49%的患者在CT上完全无结石;没有严重不良事件的报告。86%的患者根本不接受镇痛药物(50%)或轻度镇痛(36%)。在确定最佳治疗设置后,36例患者接受了治疗,有效性改善,92%(33/36),75%和58%的残余碎片≤4mm,碎片≤2mm,58%完全无石。在具有81%碎片的较低极点结石的受试者中,有效性较低,71%的碎片≤4mm,29%,碎片≤2mm,29%完全无结石;输尿管远端结石患者,89%是完全无石的。
■BWL提供了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。
■ClinicalTrials.gov标识符:NCT03811171。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: BWL offered safe and effective noninvasive stone therapy requiring little to no anesthesia and was carried out successfully in nonoperative environments.
UNASSIGNED: ClinicalTrials.gov identifier: NCT03811171.