Implantable Device for Male Reproductive Sterilization - Full Text View

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 I

U.S. FDA Resources

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

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

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

Study ID Numbers:	G050215, NIH grant # R44HD046318
First Received:	June 7, 2006
Last Updated:	April 5, 2007
ClinicalTrials.gov Identifier:	NCT00335361
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shepherd Medical Company:

Male Contraceptive Devices

Intra Vas Device (IVD)

Male Sterilization

Vasectomy

Intra Vas Deferens Occlusion

Vas Occlusion

ClinicalTrials.gov processed this record on October 14, 2008

Sponsored by:	Shepherd Medical Company
Information provided by:	Shepherd Medical Company
ClinicalTrials.gov Identifier:	NCT00335361