Proven safety, efficacy, and patient satisfaction
Study Overview1
The EASE study was conducted to demonstrate the safety and effectiveness of Adiana Permanent Contraception in 645 women from ages 18 to 45. It was a prospective, single-armed, multi-center, multi-national study that used findings from the U.S. Collaborative Review of Sterilization (CREST) study as a qualitative benchmark. The trial showed a strong safety profile, with very high device placement success, patient tolerance, comfort and satisfaction.
Primary Efficacy Endpoint:
Pregnancy prevention rate after 12 months of reliance on the matrices for contraception
Secondary Endpoints:
- Device placement rates
- Patient satisfaction and comfort with the placement procedure
- Patient satisfaction and comfort during the reliance phase
Adiana Efficacy
98.4% 3-year pregnancy prevention effectiveness rate as shown in the clinical trial
Adiana Safety1
No uterine or fallopian perforations
No adverse device reactions – no allergic reactions, no infections
No removals
Device Placement1
95% (611/645) successful bilateral placements
Anesthesia1
No patients required general anesthesia
Adiana Procedure Time1
11 minutes 54 second average procedure time
Patient Comfort & Satisfaction1
99% of patients were “very satisfied” or “satisfied” with the procedure
98% rated their tolerance of the procedure as “well” to “excellent”
98% of patients returned to normal activities in 1 or 2 days
1. Vancaille TG, Anderson TL, Johns DA. A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices.Obstet Gynecol 2008;112:1270-1277.