Implantable Device for Male Reproductive Sterilization

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Shepherd Medical Company.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shepherd Medical Company
ClinicalTrials.gov Identifier:
NCT00335361
First received: June 7, 2006
Last updated: April 5, 2007
Last verified: April 2007
  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
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


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:

  1. Subject desires to undergo a vasectomy.
  2. Freely consents to participate in the Study a
  3. Agrees to provide a semen sample at regularized periods for at least 30 months.
  4. Willing to use a redundant method of contraception until successful occlusion is confirmed.
  5. Agrees to provide follow-up information.
  6. Willing and able to understand and agree to follow all aspects of the procedures and Study requirements.
  7. At least 18 years of age.

Exclusion Criteria:

  1. Has a condition permanently or temporarily making participation in the Study inadvisable.
  2. Has a condition permanently or temporarily making a vasectomy inadvisable.
  3. Has had a previous successful/unsuccessful vasectomy.
  4. 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

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

No publications provided

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
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

Additional relevant MeSH terms:
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014