Clinical trial NCT00335361: Implantable Device for Male Reproductive Sterilization
Official title: The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Male Sterilization
Keywords: Male Contraceptive Devices
Intra Vas Device (IVD)
Male Sterilization
Vasectomy
Intra Vas Deferens Occlusion
Vas Occlusion
Lead sponsor: Shepherd Medical Company
Sponsor class: INDUSTRY
First posted: 2006-06-09
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Successful IVD implantation with vas deferens occlusion at 6 and 24 months post-implant.
measure: The IVD consists of a tubular silicone plug that is inserted into the lumen of the vas deferens to block the flow of semen.
measure: IVD implantation does not require the need to sever or permanently damage the vas deferens like the Ligation/Excision, Clip devices, Cautery
measure: techniques or Fascial Interposition require. One major advantage of the IVD is that it
measure: does not require excision and removal of a portion of the vas. Implantation of the IVD
measure: allows the vas deferens to remain intact and not be permanently damaged.
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Douglas G. Stein, MD, PA
state: Florida
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Sartell
country: United States
facility: Adult and Pediatric Urology
state: Minnesota
Study officials:
References: