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Implantable Device for Male Reproductive Sterilization
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Shepherd Medical Company.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Shepherd Medical Company
Information provided by:
Shepherd Medical Company
ClinicalTrials.gov Identifier:
NCT00335361
First received: June 7, 2006
Last updated: April 5, 2007
Last verified: April 2007
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study |
Further study details as provided by Shepherd Medical Company:
Primary Outcome Measures:
- 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.
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335361
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335361
Locations
| 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 | |
Sponsors and Collaborators
Shepherd Medical Company
More Information
| ClinicalTrials.gov Identifier: | NCT00335361 History of Changes |
| Other Study ID Numbers: |
G050215 NIH grant # R44HD046318 |
| Study First Received: | June 7, 2006 |
| Last Updated: | April 5, 2007 |
Keywords provided by Shepherd Medical Company:
|
Male Contraceptive Devices Intra Vas Device (IVD) Male Sterilization |
Vasectomy Intra Vas Deferens Occlusion Vas Occlusion |
Additional relevant MeSH terms:
|
Disinfectants Anti-Infective Agents |
ClinicalTrials.gov processed this record on July 24, 2017