FDA greenlights pivotal trial of Separo Vessel Sealing System for vasectomy

The FDA has approved an Investigational Device Exemption (IDE) application to initiate a pivotal trial of the Signati Separo Vessel Sealing System, energy-based platform designed specifically for vasectomy.¹

The pivotal trial is structured as a randomized, controlled, open-label, multicenter, non-inferiority study. Adult male patients who are seeking vasectomy will be randomly assigned to vasectomy with either the Separo Vessel Sealing System or conventional mucosal cautery vasectomy. Participants will be enrolled at up to 5 US clinical sites, with a target enrollment of 120 patients.

The primary effectiveness end point is azoospermia or rare non-motile sperm (RNMS; ≤100,000 non-motile sperm/mL) on post-vasectomy semen analysis (PVSA) within 6 months of the procedure. This threshold reflects the clinical definition of vasectomy success endorsed by the American Urological Association, which allows patients to discontinue additional contraception once a qualifying PVSA result is obtained.^2,3

The pivotal trial of the device was designed with guideline and coverage adoption in mind. According to Signati Medical, the study’s non-inferiority design, multi-center structure, and objective semen analysis end point are all intended to generate the class of evidence and meet the standards that professional societies and payers require before updating guidelines and coverage policies.

Background on the Separo System

The Separo system is described as an energy-based vessel sealing platform developed specifically for vasectomy. The technique is intended to provide urologists and surgeons with reduced technical variability and improved procedural efficiency compared with conventional vasectomy approaches, which in turn may improve access.

The Separo system's developmental history includes an earlier, smaller IDE study (NCT06402773) at Louisiana State University Medical Center, completed in December 2024 and enrolling 8 patients. All 8 participants met the primary end point (azoospermia or RNMS at 6 months), and no device-related adverse events were recorded in that single-arm safety and feasibility cohort.⁴ According to the company, these findings validated preclinical data on the device.

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