Plan A Occlusion and Reversal System Feasibility Study

Exclusion Criteria

• •1. (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.
• •2. Prior testicular surgery, testicular injury or prior vasectomy with vasovasostomy (vasectomy reversal)
• •3. Recurrent pain with ejaculations
• •4. Has known allergic reaction to sulfur-containing products or has had a prior severe allergic response to injectable or implantable devices
• •5. 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
• •6. History of prostatitis or benign prostatic hypertrophy requiring treatment
• •7. Has undergone prior chemotherapy
• •8. Has known current coagulopathy or other bleeding disorders
• •9. 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)
• •10. Subjects with cystic fibrosis
• •11. Subjects with a history of inguinal hernia repair
• •12. Vulnerable subjects (e.g., subjects with cognitive challenges, incarcerated, etc.)
• •13. 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).
• •14. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities
• •15. 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
• •16. 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.