迎接挑战:使用EndoTheia FlexStone内镜可引导篮子的初步临床经验
Kimberly A Maciolek1, Amir I Khan1, Ryan S Hsi1
1Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Journal of endourology
|February 3, 2026
概括
试验中的FlexStone可转向石篮在首次对人体进行的试验中证明了结石检索的安全性和可行性. 外科医生报告说,工作量低,性能高,这表明它对复杂病例的价值.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 内分泌病学 在内分泌病学.
- 医疗器械 医疗器械
背景情况:
- 该FlexStone设备是一个研究,可引导的石篮,旨在独立于尿道镜的曲.
- 它的目的是帮助在手术过程中提取石头,而不需要额外的助手.
研究的目的:
- 评估新型FlexStone器件用于结石检索的安全性和可行性.
- 评估手术内和短期术后的不良事件.
- 在柔性尿路透镜 (URS) 期间确定外科医生的工作量和设备性能.
主要方法:
- 这是一项首次在人身上进行的临床试验,涉及10名接受结石治疗的患者.
- FlexStone设备用于石头的提取或重新定位.
- 安全性,成功的篮子,不良事件和外科医生的工作量 (NASA-TLX) 是主要和次要的终点.
主要成果:
- 在90%的案例中,FlexStone设备成功地将目标石放在篮子里.
- 没有观察到手术期间的并发症;一名患者需要在术后进行第二次URS,而不会阻塞石头.
- 外科医生报告精神,身体和时间需求低,挫折感低,整体绩效评分高.
结论:
- 初步调查证实了FlexStone可转向石篮的安全性.
- 该设备显示出作为泌尿科医生的宝贵工具的潜力,特别是在复杂的形解剖学和改善URS人体工程学方面.
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