Essure® permanent birth control device
Research type
Research Study
Full title
A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model ESS505) Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception
IRAS ID
128843
Contact name
Justin Clark
Contact email
Sponsor organisation
Bayer HealthCare
Clinicaltrials.gov Identifier
Research summary
The Essure System to prevent pregnancy has been approved by the Food and Drug Administration (FDA) of the United States, has earned the European CE mark and has approval in several other countries. The Essure System has been marketed worldwide beginning in 2001 and over 700,000 procedures have been completed since then. The body works with the permanent implant, called the Essure inserts, to form a natural barrier (occlusion) within each fallopian tube. These barriers prevent sperm from reaching the eggs so that pregnancy cannot occur. The approved system, the ESS305 model, requires a woman wearing Essure inserts to use alternative birth control for approximately three months after Essure placement while the natural barrier is growing.
This study, sponsored by Bayer HealthCare, is to evaluate a new model of Essure, called the ESS505, a non-CE marked device. This model of Essure has a design improvement that will be studied to determine whether the changes allow women to rely on Essure as their primary birth control immediately, without having to wait three months after insert placement. The design improvement uses a new biomaterial that is a type of hydrogel. This study is being done to validate the effectiveness of the ESS505 model of Essure in preventing pregnancy.
The study will include approximately 600 women worldwide who are seeking permanent birth control. Participants will undergo ten years of follow-up. Ten years of follow-up is the standard length of time for follow-up in studies involving permanent birth control. Study recruitment is expected to last for one year; the overall expected duration of the study is 11 years.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/0007
Date of REC Opinion
12 Feb 2014
REC opinion
Further Information Favourable Opinion