A First in Human Study, Evaluating the Safety and Efficacy of ADAM™ 1.0 (NCT05134428) | Clinical Trial Compass
CompletedNot Applicable
A First in Human Study, Evaluating the Safety and Efficacy of ADAM™ 1.0
Australia25 participantsStarted 2022-05-20
Plain-language summary
This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 3 sites. This is a prospective, non-randomized, open label interventional trial.
Who can participate
Age range
25 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject is male
. Subject is 25 to 65 years of age
. 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
. Subject is suitable to undergo a vasectomy as a long-term form of contraception
. Subject is legally competent
. 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
. 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
. Subject is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study.
Exclusion criteria
. Subject is participating in another interventional clinical trial currently or within the past 3 months from the time of screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subject has history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists and antagonists) within the past 6 months
. 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
. Subject has allergic reaction to polyethylene glycol (PEG) containing products or has had a prior severe allergic response to injectable or implantable devices
. 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
. 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)
. Subject had a previous successful or unsuccessful vasectomy or vasectomy reversal