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Completed

NCT Number: NCT00663533

VAS-2 Vasectomy With the Vax-X

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.

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Key information

Conditions

Healthy

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vas-X

Device

mechanical vasectomy device

Primary outcomes

  1. absence of sperm in ejaculated semen 6 months after vasectomy

    Time frame: 6-months

Secondary outcomes

  1. any side effects as well as degree of occlusion of the resected segment of vas deferens

    Time frame: 6-months

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Acronym: VAS-2

Important dates

Study start
2008
Primary completion
2008
Study completion
2013
First posted
Apr 22, 2008
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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