Vasectomy Clinical Trial
Official title:
A Safety Study in Human Subjects Evaluating the Use of the Signati System for Vasectomy
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.
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. ;
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