A Multi-center, International Prospective Follow up Study to Assess the Safety and Efficacy of the iTind Procedure After Three to Five Years of Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 5
- 主要终点
- iTind Durability
研究概览
简要总结
The study objective is to assess the safety and efficacy of iTind three to five years following treatment.
详细描述
This study will recruit patients who participated in the MT-03 study in the iTind arm to assess the safety and efficacy of the iTind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by IPSS and QoL and improvement of functional parameters as measured by peak urinary flow and PVR. Sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject signed informed consent form (ICF)
- •Subject who had participated in the MT-03 study in the iTind arm
- •Subject able to comply with the study protocol.
排除标准
- •Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study
- •Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study.
结局指标
主要结局
iTind Durability
时间窗: 60 months post procedure
The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention.
次要结局
- iTind Efficacy(60 months post procedure)
- iTind Safety(60 months post procedure)