Plan A Occlusion and Reversal System Feasibility Study

Exclusion Criteria16

• (On exam, has any of the following); one or both vasa 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.
• Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)
• Recurrent pain with ejaculations
• Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
• Has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection
• History of prostatitis or benign prostatic hypertrophy requiring treatment
• Has undergone prior chemotherapy
• Has known current coagulopathy or other bleeding disorders
• 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)
• Subjects with cystic fibrosis
• Subjects with a history of inguinal hernia repair
• Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)
• Currently participating in another study involving an investigational device or drug (or has participated in a study within the last 30 days prior to screening).
• Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
• In the opinion of the Investigator, there are issues or concerns that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study
• Has any condition that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.