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临床试验/NCT04250090
NCT04250090Unknown不适用

Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set

En Chu Kong Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年7月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Hydronephrosis

研究概览

简要总结

Ureteral stents have been widely used in many urological operations. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents

详细描述

Ureteral stents have been widely used in many urological operations. The main purposes of placing ureteral stents include improvement of ureteral obstruction, protecting renal function and drainage of infection. Although there are several reports regarding the effectiveness of long-term ureteral stents for malignancy ureteral obstruction, ureteral stricture and urolithiasis, the experience is limited about the long-term ureteral stents made by Taiwan. Thus, The investigators will conduct this post-marketing survey to observe and investigate the changes of ureteral stents, e.g. hydronephrosis, infection and stone formation. Now this product has been approved by European Medical Device Administration. The investigators have to propose the 5-year post-market survey report. Though this observation study, The investigators can further understand the clinical safety and effectiveness of placing ureteral stents

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who used " Bioteq" Ureteral Stent Set (Long-Term Type) in their treatments.
  • Patients with complete basic parameters.

排除标准

  • Patients with any of the following conditions are excluded from this clinical study:
  • Patients with incomplete basic parameters.
  • The minorities, children and special populations

结局指标

主要结局

Hydronephrosis

时间窗: 5 years

no hydronephrosis, mild hydronephrosis, moderate hydronephrosis, severe hydronephrosis

Renal function

时间窗: 5 years

serum Creatine level

Days of stent placement

时间窗: 5 years

Mean days of stent placement

次要结局

未报告次要终点

研究者

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

ChungChengWang

Chief of urology

En Chu Kong Hospital

研究点 (1)

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