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VAS-2 Vasectomy With the Vax-X

NCT ID: NCT00663533

Last Updated: 2014-12-03

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this research study is to study an experimental vasectomy device called the Vas-X. This is an experimental study of this new approach to vasectomy.

Detailed Description

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The Vas-X works by stripping the lining of the vas deferens, the tube that sperm pass through during ejaculation. It is used in a way very similar to routine vasectomy, however, in a routine vasectomy, the vas is burned with an electrical device. With the Vas-X, there is no burning. The investigators are testing the Vas-X to determine whether it will offer a better way of performing a vasectomy.

The investigators will conduct this study at the University of Washington Medical Center, Seattle.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Device study only.

Group Type NO_INTERVENTION

Vas-X

Intervention Type DEVICE

mechanical vasectomy device

Interventions

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Vas-X

mechanical vasectomy device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy male with normal physical findings
* normal testicular volume (15-30mL)
* detectable sperm in ejaculates

Exclusion Criteria

* Men with past history of

* hypertension
* significant cardiovascular
* thromboembolic disorders
* renal (including undiagnosed urinary tract bleeding)
* hepatic, prostatic and testicular disease
* prior vasectomy or scrotal surgery
* infertility
* Men with a past history of drug abuse will also be excluded.
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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John Amory

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Amory

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Amory JK, Jessen JW, Muller C, Berger RE. Vasectomy by epithelial curettage without suture or cautery: a pilot study in humans. Asian J Androl. 2010 May;12(3):315-21. doi: 10.1038/aja.2009.94. Epub 2010 Feb 15.

Reference Type DERIVED
PMID: 20154700 (View on PubMed)

Other Identifiers

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32431-B

Identifier Type: -

Identifier Source: org_study_id