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临床试验/NCT02443909
NCT02443909Unknown4 期

Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
90
试验地点
1
主要终点
Safety (Complications according to clavien system)

研究概览

简要总结

To compare safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients who have 2-3 cm kidney stones
  • •patients who are between 18-90 years old

排除标准

  • •patients who have congenital urogenital abnormalities
  • •patients who have previous surgery history for urinary stones

研究组 & 干预措施

first group

Active Comparator

Patients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones

干预措施: Retrograde Intrarenal Surgery (Procedure)

first group

Active Comparator

Patients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones

干预措施: Holmium laser device (Device)

second group

Active Comparator

Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones

干预措施: Retrograde Intrarenal Surgery (Procedure)

second group

Active Comparator

Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones

干预措施: Holmium laser device (Device)

third group

Active Comparator

Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston

干预措施: Retrograde Intrarenal Surgery (Procedure)

third group

Active Comparator

Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston

干预措施: Holmium laser device (Device)

结局指标

主要结局

Safety (Complications according to clavien system)

时间窗: 1 day

Complications according to clavien system

Efficiency (visual analog score)

时间窗: 1 Day

visual analog score

次要结局

  • Efficiency (stone free rate)(3 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nihat Karakoyunlu

MD

Diskapi Teaching and Research Hospital

研究点 (1)

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