Essure Transvaginal Ultrasound (TVU) Study

Study Overview
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Brief Summary
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The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first permanent birth control method that can be performed in the comfort of a physician's office without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is called a hysterosalpingogram and evaluates the location of the inserts and whether the fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to evaluate the location of the inserts. The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective method of confirming micro-insert location.

Detailed Description
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This study has previously been posted by Conceptus, Inc. (USA). After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.

Official Title
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Use of Transvaginal Ultrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of Effectiveness

Conditions
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Contraceptive Usage

Intervention / Treatment
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* Device: TVU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TVU<br> | Device: TVU<br>* Use of transvaginal ultrasound to determine location of micro-insert<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Rate of pregnancy at 1 and 10 years among subjects relying on Essure micro-inserts for birth control on the basis of the TVU/HSG algorithm | Annually beginning at one year |