NCT04441320招募中不适用
Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Device related serious adverse events
研究概览
简要总结
A prospective, multicenter and controlled study to observe the efficacy and safety of coated metal ureteral stent in the treatment of radiation induced ureteral stricture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ureteral stricture and hydronephrosis.
- •Previous history of radiation therapy.
- •Must be able to tolerate surgery.
排除标准
- •Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter).
- •Colon resection surgery patients.
结局指标
主要结局
Device related serious adverse events
时间窗: Up to 36 months
Number of device related serious adverse events
Patency rate
时间窗: Up to 36 months
Number of patients evaluated with hydronephrosis
Indwelling time
时间窗: Up to 36 months
Number of months of the implant in the ureter
次要结局
未报告次要终点
研究者
Huhao
Associate Professor
Peking University People's Hospital
研究点 (1)
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