Implantable Device for Male Reproductive Sterilization

Shepherd Medical Company90 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Male Sterilization

Interventions

Intra Vas Device (IVD)DEVICE

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Douglas G. Stein, MD, PA

Tampa, Florida, United States

Regional Urology, LLC

Shreveport, Louisiana, United States

Adult and Pediatric Urology

Sartell, Minnesota, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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