The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Successful IVD implantation with vas deferens occlusion at 6 and 24 months post-implant.
研究概览
简要总结
The study is to evaluate a device for male reproductive sterilization and determine if this device is successful at blocking the sperm.
Ninety subjects from two centers in the United Stated will be followed closely for 24 months.
If you are someone interested in a vasectomy, you may be eligible to participate in this clinical study.
详细描述
This feasibility study is intended to collect pertinent clinical information on the use of the Shepherd Medical Intra Vas Device (IVD) necessary to support the design of a future pivotal study. The IVD is intended to occlude the vas deferens and thus accomplish male reproductive sterilization and to offer an additional method to vasectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject desires to undergo a vasectomy.
- •Freely consents to participate in the Study a
- •Agrees to provide a semen sample at regularized periods for at least 30 months.
- •Willing to use a redundant method of contraception until successful occlusion is confirmed.
- •Agrees to provide follow-up information.
- •Willing and able to understand and agree to follow all aspects of the procedures and Study requirements.
- •At least 18 years of age.
排除标准
- •Has a condition permanently or temporarily making participation in the Study inadvisable.
- •Has a condition permanently or temporarily making a vasectomy inadvisable.
- •Has had a previous successful/unsuccessful vasectomy.
- •Has had an allergic reaction to silicone and/or ethylene.
结局指标
主要结局
Successful IVD implantation with vas deferens occlusion at 6 and 24 months post-implant.
The IVD consists of a tubular silicone plug that is inserted into the lumen of the vas deferens to block the flow of semen.
IVD implantation does not require the need to sever or permanently damage the vas deferens like the Ligation/Excision, Clip devices, Cautery
techniques or Fascial Interposition require. One major advantage of the IVD is that it
does not require excision and removal of a portion of the vas. Implantation of the IVD
allows the vas deferens to remain intact and not be permanently damaged.
次要结局
未报告次要终点