Safety Evaluation of the ADAM System

This is an interventional device feasibility trial for Azoospermia Read More

Inclusion Criteria:

1. The subject is male
2. Subject is 25 to 65 years of age
3. Subject has a normal semen analysis (≥ 15 million sperm/mL, ≥40% total motility) defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
4. Subject is suitable to undergo a vasectomy as a long-term form of contraception
5. Subject is legally competent
6. In the opinion of the Investigator, the subject is willing and able to comply with the protocol, return for all follow-up visits and complete all protocol assessments, which includes providing recurring semen samples
7. Subject agrees to use an alternative method of contraception with any female partner of reproductive age during the course of the study treatment until study exit occurs
8. Subject is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study.
9. The subject has been informed of the nature of the study, agrees to its provisions, and has willingly provided written informed consent, approved by the appropriate Human Research Ethics Committee (HREC) -

Exclusion Criteria:

• Potential subjects will be excluded if ANY of the following criteria apply:

  1. Subject is participating in another interventional clinical trial currently or within the past 3 months from the time of screening
  2. Subject has history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists and antagonists) within the past 6 months
  3. Subject on 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
  4. Subject has allergic reaction to polyethylene glycol (PEG) containing products or has had a prior severe allergic response to injectable or implantable devices
  5. Subject has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be admitted after resolution of an acute infection
  6. Subject has current coagulopathy or other bleeding disorders
  7. 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)
  8. Subject had a previous successful or unsuccessful vasectomy or vasectomy reversal
  9. Subject has any clinically significant abnormal findings or other findings identified by Investigator that would exclude the subject.