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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The occlusion system comprised of the Delivery Lumen Access Device and Vasalgel.
Western Urology
Maribyrnong, Victoria, Australia
RECRUITINGStudy subjects achieving azoospermia
Total number of subjects (N=40) achieving azoospermia
Time frame: Starting at the 30 day follow-up visit
Study subjects that return to baseline semen levels
Total number of subjects (N=10) that return to baseline semen levels after reversal
Time frame: Correlating to Outcome 1, that follow-up timepoint at which azoospermia is reached starting at the 30 day follow-up
Adverse Events
Rate and severity of adverse events.
Time frame: From the first subjects screening visit through the last subjects 14 Day phone follow up visit.
Subject Comfort
Subject Comfort Assessment Scale Post Occlusion and Reversal
Time frame: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Histology
Excised portion of the vas deferens will be prepared with formalin for histological evaluation
Time frame: From the first subjects occlusion visit until the last subjects vasectomy, approximately 9 months
Subject Satisfaction/Comfort Assessment
Patient satisfaction questions along with NRS pain scale are being utilized to determine the comfort of the patient
Time frame: From the first subjects occlusion visit until the last subjects 14 Day phone follow up visit.
Darlene Walley R Chief Executive Officer, PhD
CONTACT
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