Implantable Device for Male Reproductive Sterilization

The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study

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.

Study Overview

• Status: Unknown
• Conditions: Male Sterilization
• Intervention / Treatment: Device: Intra Vas Device (IVD)

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.

• Study Type: Interventional
• Enrollment: 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33613
      • Douglas G. Stein, MD, PA
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Minnesota
    • Sartell, Minnesota, United States, 56377
      • Adult and Pediatric Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Shepherd Medical Company

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: June 7, 2006
• First Submitted That Met QC Criteria: June 7, 2006
• First Posted (Estimate): June 9, 2006

Study Record Updates

• Last Update Posted (Estimate): April 6, 2007
• Last Update Submitted That Met QC Criteria: April 5, 2007
• Last Verified: April 1, 2007

More Information

Terms related to this study

• Keywords: Male Contraceptive Devices; Intra Vas Device (IVD); Male Sterilization; Vasectomy; Intra Vas Deferens Occlusion; Vas Occlusion
• Other Study ID Numbers: G050215; NIH grant # R44HD046318