Plan A Occlusion and Reversal System Feasibility Study (NCT07361120) | Clinical Trial Compass
RecruitingPhase 2
Plan A Occlusion and Reversal System Feasibility Study
Australia40 participantsStarted 2026-01
Plain-language summary
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then be reversed to subsequently allow the passage of sperm through the vas deferens.
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
. Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception
. Male subject who has voluntarily signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form (ICF) for this study prior to initiation of any screening or study specific procedures
. 25 to 65 years of age at the time of consent
. Body Mass Index (BMI) \<31 kg/m2
. Good health for undergoing a vasectomy as confirmed by medical history, physical examination and clinical laboratory tests of blood and urine at the time of screening
. Normal semen analysis defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (6th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
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.
What they're measuring
1
Study subjects achieving azoospermia
Timeframe: Starting at the 30 day follow-up visit
2
Study subjects that return to baseline semen levels
Timeframe: Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
3
Adverse Events
Timeframe: From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
4
Subject Comfort
Timeframe: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
5
Histology
Timeframe: From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
. In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception
. Agreement to use an effective method of contraception during the entire clinical trial until the planned vasectomy
Exclusion criteria
. (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