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临床试验/JPRN-jRCTs042190074
JPRN-jRCTs042190074已完成未知

Evaluation of robotic assisted fluoroscopic guided percutaneous nephrolithotomy

Taguchi Kazumi0 个研究点目标入组 60 人开始时间: 2019年10月21日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
60

研究概览

简要总结

In this study, we conducted a single-center, randomized controlled trial, evaluating the safety and efficacy of an AI-empowered robot-assisted device for percutaneous renal access compared with conventional ultrasound guidance. The subjects were patients underwent percutaneous nephrolithotomy due to large renal stones. The study included each 30-cases in the ultrasound or robot group. No differences were seen in the primary and secondary endpoints between the two groups.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 16age old 至 <= 80age old(—)
性别
All

入选标准

  • 1) Patients whose age are between 16 and 80 years old, diagnosed with renal and/or upper ureteral stone at Nagoya City University Hospital, and planned for percutaneous nephrolithotomy
  • 2) Stones for 15mm and larger in size
  • 3) Patients who were obtained written informed consent
  • - obtained written informed consent from themselves if they are 20 years old and older
  • - obtained written informed consent from themselves and representatives if their age are between 16 and 19 years old

排除标准

  • A) women with pregnant or its possibility
  • B) having active pyelonephritis
  • C) under anti-platelet/coagulation therapy within 1 week prior surgery
  • D) difficult status for general/lumber anesthesia judged by anesthesiologist
  • E) Best supportive care due to terminal carcinoma

研究者

发起方
Taguchi Kazumi

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