Implantable Device for Male Reproductive Sterilization - Tabular View

Tracking Information
First Received Date ^ICMJE	June 7, 2006
Last Updated Date	April 5, 2007
Start Date ^ICMJE	September 2006
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 7, 2006)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00335361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Implantable Device for Male Reproductive Sterilization
Official Title ^ICMJE	The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Male Sterilization
Intervention ^ICMJE	Device: Intra Vas Device (IVD)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	90
Estimated Completion Date	September 2009
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: 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.
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00335361
Responsible Party
Study ID Numbers ^ICMJE	G050215, NIH grant # R44HD046318
Study Sponsor ^ICMJE	Shepherd Medical Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Shepherd Medical Company
Verification Date	April 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP