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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.
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.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intra Vas Device (IVD)
Douglas G. Stein, MD, PA
Active, not recruiting
Shepherd Medical Company
Published on BioPortfolio: 2014-07-23T21:43:33-0400
The objective of this study is to describe the proportion of hysterectomy in patients that had undergone sterilization through hysteroscopic device placement and the patients that had unde...
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Procedures to block or remove all or part of the genital tract for the purpose of rendering individuals sterile, incapable of reproduction. Surgical sterilization procedures are the most commonly used. There are also sterilization procedures involving chemical or physical means.
Reproductive sterilization without the consent of the patient.
Procedures to reverse the effect of REPRODUCTIVE STERILIZATION and to regain fertility. Reversal procedures include those used to restore the flow in the FALLOPIAN TUBE or the VAS DEFERENS.
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
A technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure. It may be achieved by intra-aortic balloon, or by implanting a special pumping device in the chest, or externally by applying a negative pressure to the lower extremities during cardiac systole.