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Status unknownNCT00335361Updated Apr 6, 2007

Implantable Device for Male Reproductive Sterilization

A Phase 1 interventional study of Intra Vas Device (IVD) in Male Sterilization, sponsored by Shepherd Medical Company. Status unknown at 3 sites in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-04-06.

Sponsored by Shepherd Medical Company · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Male Sterilization

Keywords

  • Male Contraceptive Devices
  • Intra Vas Device (IVD)
  • Male Sterilization
  • Vasectomy
  • Intra Vas Deferens Occlusion
  • Vas Occlusion
03

In context

Lead sponsor

This is the only study on the registry with Shepherd Medical Company as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants

Interventions

  • DeviceIntra Vas Device (IVD)
06

What researchers measure

Primary outcomes

  1. Successful IVD implantation with vas deferens occlusion at 6 and 24 months post-implant.

  2. The IVD consists of a tubular silicone plug that is inserted into the lumen of the vas deferens to block the flow of semen.

  3. IVD implantation does not require the need to sever or permanently damage the vas deferens like the Ligation/Excision, Clip devices, Cautery

  4. techniques or Fascial Interposition require. One major advantage of the IVD is that it

  5. does not require excision and removal of a portion of the vas. Implantation of the IVD

  6. allows the vas deferens to remain intact and not be permanently damaged.

07

Study locations

3 sites
  • Douglas G. Stein, MD, PA
    Tampa, Florida 33613, United States
  • Regional Urology, LLC
    Shreveport, Louisiana 71106, United States
  • Adult and Pediatric Urology
    Sartell, Minnesota 56377, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00335361
Lead sponsor
Shepherd Medical Company
First posted
Jun 9, 2006
Start date
Sep 2006
Completion
Sep 2009 (estimated)
Last update
Apr 6, 2007
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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