Plan A Occlusion and Reversal System Feasibility Study
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male subject who is seeking and suitable to undergo a vasectomy as a long-term form of contraception 2. 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 3. 25 to 65 years of age at the time of consent 4. Body Mass Index (BMI) \<31 kg/m2 5. 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 6. 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 7. In the opinion of the Investigator, subject is suitable to undergo a vasectomy as a form of long-term contraception 8. Agreement to use an effective method of contraception during the entire cli