Implantable Device for Male Reproductive Sterilization
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study|
- 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.
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||September 2009|
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.
|United States, Florida|
|Douglas G. Stein, MD, PA|
|Tampa, Florida, United States, 33613|
|United States, Louisiana|
|Regional Urology, LLC|
|Shreveport, Louisiana, United States, 71106|
|United States, Minnesota|
|Adult and Pediatric Urology|
|Sartell, Minnesota, United States, 56377|