Male Sterilization
Conditions
Keywords
Male Contraceptive Devices, Intra Vas Device (IVD), Male Sterilization, Vasectomy, Intra Vas Deferens Occlusion, Vas Occlusion
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.
Interventions
DEVICEIntra Vas Device (IVD)
Sponsors
Shepherd Medical Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject desires to undergo a vasectomy. 2. Freely consents to participate in the Study a 3. Agrees to provide a semen sample at regularized periods for at least 30 months. 4. Willing to use a redundant method of contraception until successful occlusion is confirmed. 5. Agrees to provide follow-up information. 6. Willing and able to understand and agree to follow all aspects of the procedures and Study requirements. 7. At least 18 years of age.
Exclusion criteria
1. Has a condition permanently or temporarily making participation in the Study inadvisable. 2. Has a condition permanently or temporarily making a vasectomy inadvisable. 3. Has had a previous successful/unsuccessful vasectomy. 4. Has had an allergic reaction to silicone and/or ethylene.
Design outcomes
Primary
| Measure | 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. | — |
Countries
United States
Outcome results
None listed