Plan A Occlusion and Reversal System Feasibility Study

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.

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. 40 men (all sites) will be enrolled and treated with Plan A occlusion (Vasalgel®) using DLAD (Delivery Lumen Access Device). The study will enroll into two groups. Group 1 will include 30 subjects that will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will be offered a vasectomy procedure. Group 2 will recruit ten subjects who will be followed for up for a maximum of 6 months post occlusion procedure, or until they achieve azoospermia at which point they will have the reversal procedure using the Plan A RD (Reversal Device). This group will be followed for up to another 3 months maximum, or until baseline semen levels are achieved at which point they will be offered a vasectomy procedure. Ten men reaching azoospermia after their occlusion procedure will be allocated to Group 2 and will go on to have the reversal procedure.