Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
This study has previously been posted by Conceptus, Inc. (USA).
After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
Age
21–44
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Women who are 21 to 44 years of age
Women who are between 90-300 pounds (40-136 kilograms)
Women who are scheduled to undergo an Essure micro-insert placement procedure for permanent birth control
Women who are willing to accept the risk of pregnancy occurring while relying on the Essure device for prevention of pregnancy
Women who are believed to have two viable fallopian tubes
Women who are able and willing to provide written informed consent
Women who have the mental capacity to understand the Informed Consent, comply with the protocol requirements, and provide reliable feedback regarding device wearing
Women who can be available for all study visits
Women who are willing to allow data to be shared with the sponsor and with regulatory bodies
Women who are not contraindicated for the Essure procedure according to the Essure Instructions for Use (IFU)
You may not be if
Women who have known proximal tubal occlusion in either fallopian tube
Women who have had a fallopian tube sterilization procedure
Women who have a unicornuate uterus
Women who have known endometrial or myometrial pathology that is likely to prevent access to the fallopian tube ostia
Women who are scheduled to undergo any other intrauterine procedures at the time of Essure placement
Women who are pregnant or suspected of being pregnant
Women who have had a delivery or termination of pregnancy within the last six weeks
Women who have an active or recent upper or lower pelvic infection
Women who are contraindicated for Essure micro-insert placement according to the Essure Instructions for Use (IFU)
Women who have a known intolerance to transvaginal imaging
