VAS-2 Vasectomy With the Vax-X

University of Washington

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: Vas-X

Study type: Interventional

Funder types: Other

Identifiers

NCT00663533

32431-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Device study only.

No Intervention group

Treatment:

Device: Vas-X