(137) Sealed Vasectomy Procedure Prior Studies and Now Good Laboratory Practices FDA Study: Human, Porcine, Canine and Rabbit Subjects

Abstract

Abstract Introduction The Sealed Vasectomy Procedure (SVP) is a new bipolar radiofrequency sealing tool for transdermal vasectomy in hopes of making the procedure a faster, simpler, and safer office procedure. Testing has been successful in rabbits with excellent wound healing, complete vas occlusion on histology, and no sperm in post procedural semen analysis. Further studies in larger animals were then done in canine, porcine and human vas deferens that showed good sealing of the vas deferens. FDA-approval are needed before its application in humans. The next step in FDA approval process is a FDA prescribed Good Laboratory Practices (GLP) animal study. Objective Evaluate the effectiveness of the SVP in sealing the vas deferens in rabbit, canine, porcine and in humans. Now presenting the FDA prescribed GLP study. Methods Rabbit studies have been previously described including AUA22 best video award. We preformed microscopic evaluation of the vas deferens tissues from canines treated with the SVP at either 40 or 60 watts, euthanized at 14 days post-treatment under the conditions of this study. Human vas deferens specimens after removal from the patient were then immediately treated with SVP tool on benchtop. Porcine vas deferens samples were procured and underwent benchtop testing. The GLP study was done at Charles River in Kalamazoo, Michigan. The GLP study was on 6 canines: 3 with the outside the skin method and 3 canines with the transdermal method. All were terminal after a period of healing of up to 28 days. Results 9 canine, 6 human, and 20 porcine vas deferens were included in SVP testing. Human, porcine, and canine specimens demonstrated tissue coagulation and fibrosis in the treated vasa deferentia by Pathology. (See Figure 1 Human and 2 Canine) For the FDA GLP prescribed study, all 6 dogs survived and were euthanized at 28 days post-treatment. Pathology for the GLP study was done by Charles River. Conclusions SVP is a potentially exciting novel vasectomy procedure that appears to provide good sealing of the vas deferens in the rabbit & canine animal model and on benchtop for the human & porcine vas deferens. The FDA GLP study is done and awaits FDA submission. FDA-approval is still needed before use in humans. Disclosure Yes, this is sponsored by industry/sponsor: Signati. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Signati.