Reproductive Sterilization Clinical Trial
Official title:
A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial
The purpose of this study is to demonstrate the safety & efficacy of the Adiana Transcervical Sterilization System for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes.
Participants who demonstrated to be bilaterally occluded by hysterosalpingogram (HSG)
evaluations are allowed to rely on the Adiana System for pregnancy prevention and enter the
Wearing Period of follow-up.
Secondary endpoints inlcude safety of device placement procedure and safety of device
wearing. The adverse events recorded during the course of the study are entered under
adverse events.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science