VAS-2 Vasectomy With the Vax-X (VAS-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00663533
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
John Amory, University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Device: Vas-X Phase 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vasectomy With the Vas-X, a Simple, Minimally Invasive Device for Male Sterilization: A Pilot Study
Study Start Date : April 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasectomy

Arm Intervention/treatment
No Intervention: Device study only. Device: Vas-X
mechanical vasectomy device

Primary Outcome Measures :
  1. absence of sperm in ejaculated semen 6 months after vasectomy [ Time Frame: 6-months ]

Secondary Outcome Measures :
  1. any side effects as well as degree of occlusion of the resected segment of vas deferens [ Time Frame: 6-months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00663533

United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: John Amory University of Washington

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: John Amory, Professor, University of Washington Identifier: NCT00663533     History of Changes
Other Study ID Numbers: 32431-B
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by John Amory, University of Washington: