VAS-2 Vasectomy With the Vax-X (VAS-2)

December 2, 2014 updated by: John Amory, University of Washington

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Device study only.
Device: Vas-X
mechanical vasectomy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
absence of sperm in ejaculated semen 6 months after vasectomy
Time Frame: 6-months
6-months

Secondary Outcome Measures

Outcome Measure
Time Frame
any side effects as well as degree of occlusion of the resected segment of vas deferens
Time Frame: 6-months
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: John Amory, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 32431-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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