VAS-2 Vasectomy With the Vax-X - Tabular View

Tracking Information

First Received Date ^ICMJE

April 18, 2008

Last Updated Date

September 22, 2009

Start Date ^ICMJE

April 2008

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00663533 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

VAS-2 Vasectomy With the Vax-X

Official Title ^ICMJE

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

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Device: Vas-X

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

December 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

30 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00663533

Responsible Party

John K Amory, MD, MPH, University of Washington

Study ID Numbers ^ICMJE

32431-B

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

John Amory

University of Washington

Information Provided By

University of Washington

Verification Date

September 2009

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