NCT02398578终止1 期
Cystoscopic Ablation Via RF Energy Clinical Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Device-related complications through 24 month follow-up
研究概览
简要总结
Phase I/II study to assess the safety and performance of the Amphora OAB system for treatment of urgency and frequency with or without urge incontinence caused by an overactive bladder.
详细描述
The study will enroll subjects with symptomatic idiopathic overactive bladder (OAB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Device-related complications through 24 month follow-up
时间窗: 24 month
次要结局
- Procedural Success(During the study procedure)
- Change from Baseline of Quality of Life Scores(4 weeks, 12 weeks, 6, 12, 18, and 24 months)
- Device Technical Success(During the study procedure)
研究者
研究点 (4)
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