A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy

Inclusion Criteria:

• 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 theprotocol, return for all follow-up visits and complete all protocol assessments, whichincludes providing recurring semen samples
• Subject agrees to use an alternative method of contraception with any female partnerof 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 theduration of the study

Exclusion Criteria:

• Subject is participating in another interventional clinical trial currently or withinthe past three months at the time of screening
• Subject has a history of prior hormonal therapy use (e.g., androgenic steroids, GnRHagonists, and antagonists) within the past six months
• Subject on the exam has any of the following: vas not present, abnormal scrotum, largevaricocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal massthat would make the subject not suitable for the study or any anatomical finding thatthe investigator deems not suitable for the study
• Subject has an allergic reaction to any of the components of the system
• The subject has local genital infections such as balanitis, scrotal skin infection,epididymitis, orchitis, or tender (inflamed) tip of the penis (Note: subject t may beenrolled after the resolution of an acute infection)
• Subject has current coagulopathy or other bleeding disorders
• Subject currently taking or planning to take any type of systemic medication whichcould affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy,alpha-blocker)
• The subject had a previous successful or unsuccessful vasectomy or vasectomy reversal
• The subject has any clinically significant abnormal findings or other findingsidentified by the investigator that would exclude the subject
• The subject has a condition that in the opinion of the physician may impede woundhealing (e.g., immunosuppression, severe diabetes, scarring condition)
• The subject has testicular nodules, history of active testicular cancer, or any activelower urinary tract cancer.
• The subject has cystic fibrosis
• The subject is identified as a member of a vulnerable subject populations, such as theincarcerated or cognitively impaired, since they may be unduly convinced toparticipate in a clinical study which may lead to compromising the ethical integrityof the clinical study.