Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT01327105
Eligibility Criteria:
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
44 Years
Study:
NCT01327105
Study Brief:
Protocol Section:
NCT01327105