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

Exclusion Criteria

• •Subject is participating in another interventional clinical trial currently or within the past three months at the time of screening
• •Subject has a history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists, and antagonists) within the past six months
• •Subject on the exam has any of the following: vas not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study or any anatomical finding that the 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 be enrolled 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 which could 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 findings identified by the investigator that would exclude the subject
• •The subject has a condition that in the opinion of the physician may impede wound healing (e.g., immunosuppression, severe diabetes, scarring condition)
• •The subject has testicular nodules, history of active testicular cancer, or any active lower urinary tract cancer.
• •The subject has cystic fibrosis
• •The subject is identified as a member of a vulnerable subject populations, such as the incarcerated or cognitively impaired, since they may be unduly convinced to participate in a clinical study which may lead to compromising the ethical integrity of the clinical study.