VAS-2 Vasectomy With the Vax-X - Full Text View

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Vasectomy With the Vas-X, a Simple, Minimally Invasive Device for Male Sterilization: A Pilot Study

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:	12
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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. We are testing the Vas-X to determine whether it will offer a better way of performing a vasectomy.

We 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

The Center for Research in Reproduction and Contraception is dedicated to basic and clinical research focused primarily on the male reproductive system. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	University of Washington ( John K Amory, MD, MPH )
Study ID Numbers:	32431
First Received:	April 18, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00663533
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:

Vasectomy

Contraception

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	University of Washington
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00663533