NCT06402773

A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Signati Medical Inc · Industry
• Sex: Male
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of the Signati SeparoTM System when used in general surgical procedures where ligation and division of vessels are desired, such as the vas deferens. This study will evaluate the Signati SeparoTM System as a vasectomy device.

Detailed description

This study is designed to be a prospective, non-randomized safety study of eight subjects treated at up to three clinical sites in the United States. The primary objective of this study will be to evaluate procedural and post treatment safety and effectiveness of the Signati SeparoTM System treatment via the incidence of adverse events and evaluation of semen post-procedure. This group of subjects will continue to be followed for safety and efficacy for 6 months.

Conditions

• Vasectomy

Interventions

Type	Name	Description
DEVICE	The Signati Separo™ Vessel Sealing System	Vessel Sealing System

Timeline

• Start date: 2024-04-05
• Primary completion: 2024-11-30
• Completion: 2024-12-30
• First posted: 2024-05-07
• Last updated: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study