Post-Marketing Follow-Up of Long-term Type Ureteral Stent Set
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
- 否
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
ChungChengWang
Chief of urology
En Chu Kong Hospital
