Implantable Device for Male Reproductive Sterilization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00335361|
Recruitment Status : Unknown
Verified April 2007 by Shepherd Medical Company.
Recruitment status was: Active, not recruiting
First Posted : June 9, 2006
Last Update Posted : April 6, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Male Sterilization||Device: Intra Vas Device (IVD)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study|
|Study Start Date :||September 2006|
|Estimated Study Completion Date :||September 2009|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335361
|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|