Status:
UNKNOWN
Implantable Device for Male Reproductive Sterilization
Lead Sponsor:
Shepherd Medical Company
Conditions:
Male Sterilization
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 f...
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 IV...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00335361
Start Date
September 1 2006
End Date
September 1 2009
Last Update
April 6 2007
Active Locations (3)
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1
Douglas G. Stein, MD, PA
Tampa, Florida, United States, 33613
2
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
3
Adult and Pediatric Urology
Sartell, Minnesota, United States, 56377