Healthy
Conditions
Keywords
Vasectomy, Contraception
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. 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.
Interventions
DEVICEVas-X
mechanical vasectomy device
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| absence of sperm in ejaculated semen 6 months after vasectomy | 6-months |
Secondary
| Measure | Time frame |
|---|---|
| any side effects as well as degree of occlusion of the resected segment of vas deferens | 6-months |
Countries
United States
Outcome results
None listed