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Implantable Device for Male Reproductive Sterilization

NCT ID: NCT00335361

Last Updated: 2007-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-09-30

Brief Summary

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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

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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.

Conditions

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Male Sterilization

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Intra Vas Device (IVD)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shepherd Medical Company

INDUSTRY

Sponsor Role lead

Locations

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Douglas G. Stein, MD, PA

Tampa, Florida, United States

Site Status

Regional Urology, LLC

Shreveport, Louisiana, United States

Site Status

Adult and Pediatric Urology

Sartell, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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NIH grant # R44HD046318

Identifier Type: -

Identifier Source: secondary_id

G050215

Identifier Type: -

Identifier Source: org_study_id