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CompletedNCT00663533VAS-2Updated Dec 3, 2014

VAS-2 Vasectomy With the Vax-X

A Phase 1 interventional study of Vas-X in Healthy, sponsored by University of Washington. Completed at 1 site in United States. Open to male participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by University of Washington · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
30 Years to 55 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • Vasectomy
  • Contraception
03

In context

Lead sponsor

University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • healthy male with normal physical findings
  • normal testicular volume (15-30mL)
  • detectable sperm in ejaculates

Exclusion criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • No intervention
    Device study only.

    Device: Vas-X

Interventions

  • DeviceVas-X

    mechanical vasectomy device

06

What researchers measure

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

07

Study locations

1 site
  • University of Washington
    Seattle, Washington 98195, United States
08

References and documents

Publications

  • 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. PubMed 20154700 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2008, a primary completion of Jul 2008 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 18, 2008
First posted
Apr 22, 2008
Start
Apr 2008
Primary completionActual
Jul 2008
CompletionActual
Jul 2013
Last update
Dec 3, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00663533
Responsible party
John Amory (Professor, University of Washington) — Principal investigator
First posted
Apr 22, 2008
Start date
Apr 2008
Primary completion
Jul 2008
Completion
Jul 2013
Last update
Dec 3, 2014

Study contacts

John Amory
principal investigator · University of Washington

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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