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

April 18, 2008
October 8, 2013
April 2008
July 2009   (final data collection date for primary outcome measure)
absence of sperm in ejaculated semen 6 months after vasectomy [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00663533 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
VAS-2 Vasectomy With the Vax-X
Vasectomy With the Vas-X, a Simple, Minimally Invasive Device for Male Sterilization: A Pilot Study

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy
Device: Vas-X
mechanical vasectomy device
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
January 2015
July 2009   (final data collection date for primary outcome measure)

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.
Male
30 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663533
32431-B
No
John Amory, University of Washington
University of Washington
Not Provided
Principal Investigator: John Amory University of Washington
University of Washington
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP