NCT01788865Unknown4 期
Efficacy and Safety of a Covered Self-expandable Dual-layered Metallic Mesh Stent (UVENTA™) in Ureteral Obstruction: Prospective, Multi-center, Open Label Study
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Primary patency rate
研究概览
简要总结
The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.
详细描述
Prospective, Multi-center, open label, single arm Study
- Treatment
- Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction
- Follow up
- Assessments including X-ray(KUB), are done 3, 6, 12, 18 and 24 months after the procedure.
- Diuretic RI scan (DTPA, MAG-3) 3, 6, 12 months after the procedure
- Imaging such as IVP(Intravenous Pyelogram), ultrasonogram, CT(Computed Tomogram) are performed at 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who voluntarily agree to participation and submitted a written informed consent for this study, and 20~80 years
- •One out of following cases below apply to Patients who have malignant ureteral obstruction or have benign ureteral obstruction without improvement after previous treatment
- •Patients who doesn't want to have regular replacement of plastic stent
- •Patients who has no improvement of obstruction after plastic stent implant
- •Patients who want other Urinary diversion because of stimulatory sign or pain due to plastic stent
- •Patients with no previous ureteral metal stenting procedure experience.
- •Patients with more than 6 months of life expectancy
- •Patients understanding the objective of the study and who are willing to sign a consent
排除标准
- •Patients with Urothelial Carcinoma
- •Patients with bladder invasion of malignant tumor
- •Patients with bladder dysfunction or obstruction of lower urinary tract
- •one or more times Recurrent Urinary stone in the last 3 years
- •2 or more times upper urinary tract infection without upper urinary tract obstruction
- •Karnofsky scores < 60
- •Patients with Bacteriuria
- •Inadequate Patient to participate in the study as judged by the investigator
结局指标
主要结局
Primary patency rate
时间窗: 12 months
Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ \< 20 min)
次要结局
- Technical success rate(1week, 1 month)
- Final patency rate(12 months)
- Adverse Event(1week, 1, 3, 6, 9, 12 months)
- Predictive Risk Factors for Primary patency rate(12 months)
- the primary patency rate among different location of distal stent(12 months)
- Ureteral stent symptom questionnaire(USSQ)(1, 3, 6, 9, 12 months)
研究者
HAN, DEOK HYUN
HAN, DEOK HYUN
Samsung Medical Center
研究点 (2)
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