James B Presthus MD, Presenter: Consultant, Hologic, Inc Speaker, Hologic, Inc Researcher, Hologic, Inc Consultant, Olympus Corporation Speaker, Olympus Corporation Consultant, Viveve, Inc Consultant, American Medical Systems Speaker, American Medical Systems

Edward G Evantash MD, Abstract Co-Author: Medical Director, Hologic, Inc

To assess the transvaginal ultrasound (TVUS) detection of silicon matrices in women participating in the Evaluation of the Adiana® System for Transcervical Sterilization (EASE) pivotal trial with bilateral tubal occlusion documented by hysterosalpingography (HSG). 1

EASE was a prospective, international, multicenter trial that examined the safety and efficacy of the Adiana Permanent Contraception procedure in 645 women between the ages of 18-45. The Adiana system is based upon insertion and total integration of silicon matrices within the fallopian tubes. TVUS was performed at 1 week and 3 months post-procedure to detect the placement of the silicon matrices. A HSG was performed at 3 months to confirm bilateral tubal occlusion and ability of women to rely on the device for permanent contraception. If bilateral occlusion was not confirmed, a second HSG was done at 6 months. A retrospective analysis was performed to compare TVUS and HSG results.

Bilateral placement of the silicon matrices was confirmed in 611 of 645 (94.7%) subjects of which 603 returned for all confirmation studies.1 HSG results confirmed bilateral tubal occlusion in 570 of 645 (88.4%) subjects at 6 months.1 At 1 week and 3 months post-procedure, all 570 subjects (100%) with bilateral occlusion confirmed by HSG had matrices identified bilaterally by TVUS.

The results of this study show that matrices are detected by TVUS in all subjects with bilateral tubal occlusion confirmed by HSG after the Adiana procedure. TVUS is not required when tubal occlusion is confirmed by HSG.

HSG is required to confirm bilateral tubal occlusion and the ability to rely on Adiana for permanent contraception. TVUS is an additional test that does not increase diagnostic confidence.

Presthus, J, Evantash, E, Transvaginal Ultrasound Detection of Silicone Matrices and HSG Results in the Evaluation of a Permanent Contraception Procedure for Transcervical Sterilization (EASE) Pivotal Trial.  Radiological Society of North America 2011 Scientific Assembly and Annual Meeting, November 26 - December 2, 2011 ,Chicago IL. http://archive.rsna.org/2011/11008244.html