NCT04129645Unknown不适用
Prospective Observational Study for Assessment of the Efficacy and Safety of Allium Ureteral Stent Long-term Indwelling in the Treatment of Ureteral Stricture
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Device related serious adverse events
研究概览
简要总结
A prospective observational study aimed to assess the efficacy and safety of Allium ureteral stent long-term indwelling in the treatment of ureteral stricture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Benign diseases: UPJ, ischemic injury caused by surgical separation, endoscopic surgery injury, heat injury by laser lithotripsy, infection (chronic inflammation, tuberculosis), peri-ureteral fibrosis caused by endometriosis, ureteral anastomotic stenosis after renal transplantation, ureteral fistula, multiple polyps;
- •Malignant diseases: ureteral anastomotic stricture after urinary diversion, stricture caused by compression of abdominal and/or pelvic tumors, stricture caused by urinary tract tumors, stricture caused by radiotherapy for colon or cervical cancer, ureteral fistula
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
Primary Investigator
Peking University People's Hospital
研究点 (1)
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