A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy
The purpose of this study is to evaluate the safety and effectiveness of the Signati SeparoTM System when used in general surgical procedures where ligation and division of vessels are desired, such as the vas deferens. This study will evaluate the Signati SeparoTM System as a vasectomy device.
• The subject must sign a written informed consent form
• The subject is male and in stable, monogamous, heterosexual relationship
• The subject is 25 to 65 years of age
• The subject has a normal semen analysis (≥ 10 million sperm/mL, ≥30% total motility) defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition).
• The subject is suitable to undergo a vasectomy as a long-term form of contraception
• The subject is legally competent
• In the opinion of the investigator, the subject is willing and able to comply with the protocol, return for all follow-up visits and complete all protocol assessments, which includes providing recurring semen samples
• Subject agrees to use an alternative method of contraception with any female partner of reproductive age during the course of the study until study exit occurs
• The subject is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study