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Sponsored by: |
Shepherd Medical Company |
---|---|
Information provided by: | Shepherd Medical Company |
ClinicalTrials.gov Identifier: | NCT00335361 |
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.
Condition | Intervention | Phase |
---|---|---|
Male Sterilization |
Device: Intra Vas Device (IVD) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study |
Estimated Enrollment: | 90 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2009 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Douglas G. Stein, MD, PA | |
Tampa, Florida, United States, 33613 | |
United States, Louisiana | |
Regional Urology, LLC | |
Shreveport, Louisiana, United States, 71106 | |
United States, Minnesota | |
Adult and Pediatric Urology | |
Sartell, Minnesota, United States, 56377 |
Study ID Numbers: | G050215, NIH grant # R44HD046318 |
Study First Received: | June 7, 2006 |
Last Updated: | April 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00335361 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Male Contraceptive Devices Intra Vas Device (IVD) Male Sterilization |
Vasectomy Intra Vas Deferens Occlusion Vas Occlusion |
Contraceptive Agents Contraceptive Agents, Male |