Plan A Novel Delivery Device 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 an 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. 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.
• •4. History of prostatitis or benign prostatic hypertrophy requiring treatment.
• •5. Has known current coagulopathy or other bleeding disorders.
• •6. Known allergy to DLAD materials including nickel, stainless steel and silicone.
• •7. Has cystic fibrosis.
• •8. Has history of inguinal hernia repair.
• •9. The subject belongs to a vulnerable population. Vulnerable subject populations are defined as individuals who are incarcerated, handicapped, have cognitive challenges, mental disability, persons in nursing homes, children, impoverished persons, homeless persons, economically or educationally disadvantaged persons, nomads, refugees and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces and persons kept in detention.
• •10. Currently participating in another study involving an investigational device or drug within the last 30 days prior to the first screening.
• •11. Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
• •12. 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.
• •13. Has any condition that, in the opinion of the Investigator, would interfere with evaluation of DLAD product performance or interpretation of patient safety or study results.