VAS-2 Vasectomy With the Vax-X

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John Amory, University of Washington
ClinicalTrials.gov Identifier:
NCT00663533
First received: April 18, 2008
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Healthy
Device: Vas-X
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vasectomy With the Vas-X, a Simple, Minimally Invasive Device for Male Sterilization: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • absence of sperm in ejaculated semen 6 months after vasectomy [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • any side effects as well as degree of occlusion of the resected segment of vas deferens [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: April 2008
Estimated Study Completion Date: January 2015
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Vas-X
    mechanical vasectomy device
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.

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663533

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

Additional Information:
No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Amory, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00663533     History of Changes
Other Study ID Numbers: 32431-B
Study First Received: April 18, 2008
Last Updated: October 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
Vasectomy
Contraception

ClinicalTrials.gov processed this record on April 21, 2014