Implantable Device for Male Reproductive Sterilization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study

Conditions
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Male Sterilization

Intervention / Treatment
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* Device: Intra Vas Device (IVD)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intra Vas Device (IVD)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Contraceptive Devices, Intra Vas Device (IVD), Male Sterilization, Vasectomy, Intra Vas Deferens Occlusion, Vas Occlusion