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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014