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 range25 Years – 65 Years
SexMALE
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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
✓. 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)
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
✕. 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