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Tracking Information | |
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First Received Date † | June 7, 2006 |
Last Updated Date | April 5, 2007 |
Start Date † | September 2006 |
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00335361 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Implantable Device for Male Reproductive Sterilization |
Official Title † | 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 † | Interventional |
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Condition † | Male Sterilization |
Intervention † | 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. |
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Recruitment Information | |
Recruitment Status † | Active, not recruiting |
Enrollment † | 90 |
Estimated Completion Date | September 2009 |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male |
Ages | 18 Years and older |
Accepts Healthy Volunteers | Yes |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00335361 |
Responsible Party | |
Secondary IDs †† | NIH grant # R44HD046318 |
Study Sponsor † | Shepherd Medical Company |
Collaborators †† | |
Investigators † | |
Information Provided By | Shepherd Medical Company |
Verification Date | April 2007 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |