NCT07538622招募中不适用
Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 13
- 主要终点
- Effectiveness - IPSS
研究概览
简要总结
The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
排除标准
- •Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
结局指标
主要结局
Effectiveness - IPSS
时间窗: Baseline to 12 Months
The primary effectiveness endpoint is the change in IPSS from baseline over time
Safety - adverse events
时间窗: Baseline to 12 Months
The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs)
次要结局
未报告次要终点
研究者
研究点 (13)
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