Vasectomy With the Vas-X, a Simple, Minimally Invasive Device for Male Sterilization: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- absence of sperm in ejaculated semen 6 months after vasectomy
研究概览
简要总结
The purpose of this research study is to study an experimental vasectomy device called the Vas-X. This is an experimental study of this new approach to vasectomy.
详细描述
The Vas-X works by stripping the lining of the vas deferens, the tube that sperm pass through during ejaculation. It is used in a way very similar to routine vasectomy, however, in a routine vasectomy, the vas is burned with an electrical device. With the Vas-X, there is no burning. The investigators are testing the Vas-X to determine whether it will offer a better way of performing a vasectomy.
The investigators will conduct this study at the University of Washington Medical Center, Seattle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male with normal physical findings
- •normal testicular volume (15-30mL)
- •detectable sperm in ejaculates
排除标准
- •Men with past history of
- •hypertension
- •significant cardiovascular
- •thromboembolic disorders
- •renal (including undiagnosed urinary tract bleeding)
- •hepatic, prostatic and testicular disease
- •prior vasectomy or scrotal surgery
- •infertility
- •Men with a past history of drug abuse will also be excluded.
结局指标
主要结局
absence of sperm in ejaculated semen 6 months after vasectomy
时间窗: 6-months
次要结局
- any side effects as well as degree of occlusion of the resected segment of vas deferens(6-months)
研究者
John Amory
Professor
University of Washington