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.
This study has previously been posted by Conceptus, Inc. (USA). After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
547
Use of transvaginal ultrasound to determine location of micro-insert
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Glendale, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Arvada, Colorado, United States
Unnamed facility
Fort Wayne, Indiana, United States
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Saginaw, Michigan, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
The Bronx, New York, United States
Unnamed facility
Asheville, North Carolina, United States
...and 11 more locations
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
Time frame: Annually beginning at one year
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