Implantable Device for Male Reproductive Sterilization

Status unconfirmed · Phase 1

Conditions studied: Male Sterilization

In brief

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.

Key facts

Study ID

NCT00335361

Run by

Shepherd Medical Company

People needed

90

Starts

2006-09-01

Expected to finish

2009-09-01

Last updated by the study team

2007-04-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Douglas G. Stein, MD, PA — Tampa, Florida, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Adult and Pediatric Urology — Sartell, Minnesota, United States

Full record on ClinicalTrials.gov

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