Clinical trial NCT01327105: Essure Transvaginal Ultrasound (TVU) Study
Official title: Use of Transvaginal Ultrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraceptive Usage
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 547
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: This study has previously been posted by Conceptus, Inc. (USA).

After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.

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

Primary outcomes:
measure: Effectiveness
timeFrame: Annually beginning at one year
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Arvada
country: United States
state: Colorado
city: Fort Wayne
country: United States
state: Indiana
city: Saginaw
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Bronx
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Regina
country: Canada
state: Saskatchewan
city: Amsterdam
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Tiel
country: Netherlands
city: Veldhoven
country: Netherlands
city: Zwolle
country: Netherlands
city: Córdoba
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Vleugels M, Cheng RF, Goldstein J, Bangerter K, Connor V. Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1128-1135. doi: 10.1016/j.jmig.2017.06.021. Epub 2017 Jun 29.