NCT00737061

Safety & Efficacy Study of the Adiana System for Women Who Desire Permanent Birth Control (Sterilization)

A Multi-Center, Prospective Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy in Women Aged 18-45 - The EASE Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 770 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Reproductive Sterilization

Interventions

Type	Name	Description
DEVICE	Adiana Transcervical Sterilization System	Implantation of silicone matrix in fallopian tubes

Timeline

• Start date: 2002-11-01
• Primary completion: 2005-12-01
• Completion: 2013-02-04
• First posted: 2008-08-18
• Last updated: 2017-09-08
• Results posted: 2013-01-25

Locations

16 sites across 3 countries: United States, Australia, Mexico