(083) FDA HUMAN STUDY TRIAL ON THE SEALED VASECTOMY PROCEDURE APPEARS TO BE SAFE AND EFFECTIVE

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 animal models with excellent wound healing, complete vas occlusion on histology, and no sperm in post procedural semen analysis. In this next step of device testing, we present our initial human data. Objective Evaluate the safety and effectiveness of the SVP in sealing the vas deferens in humans. Methods After FDA and IRB approval, 8 male patients were enrolled in the trial. Pre-procedure semen analysis was performed to ensure sperm present for each participant. Each then underwent office-based, minimally invasive vasectomy using Signati Separo device, with treatment occurring outside of the scrotum/skin. They were then seen at 30 days post-procedure with plans for a 3 month and 6 month post-procedure office visit and semen analysis to collect efficacy and further safety data. Results To date, 6 of the 8 patients have undergone sealed vasectomy procedure. Mean procedure time was 19.05 minutes while mean sealing time was 3.58 seconds per vas deferens. All patients had sealing and separation of each vas deferens as confirmed by the treating provider. Only one 30 day pain score was greater than zero (1). No patient has experienced an adverse event to date. Five out of six pathology specimens noted complete obliteration of the lumen with the remaining noting complete transection. Post-procedure semen analyses are currently pending for all patients. Conclusions Based on our limited human data to date, Signati sealed vasectomy procedure appears to be safe and effective in performing vasectomies in humans. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Signati Medical.