Trial Condition(s):

Contraceptive Usage

Essure Transvaginal Ultrasound (TVU) Study

Bayer Identifier:

16974

ClinicalTrials.gov Identifier:

NCT01327105

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
547
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Essure (ESS305, BAY1454032)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Tucson, United States, 85712

Status
Active, not recruiting
 
Locations

Investigative Site

Columbus, United States, 43231

Status
Active, not recruiting
 
Locations

Investigative Site

Winston-Salem, United States, 27103

Status
Active, not recruiting
 
Locations

Investigative Site

Saginaw, United States, 48604

Status
Active, not recruiting
 
Locations

Investigative Site

Phoenix, United States, 85032

Status
Active, not recruiting
 
Locations

Investigative Site

Rochester, United States, 55905

Status
Active, not recruiting
 
Locations

Investigative Site

Houston, United States, 77074

Status
Active, not recruiting
 
Locations

Investigative Site

Asheville, United States, 28801

Status
Active, not recruiting
 
Locations

Investigative Site

Bronx, United States, 10467

Status
Active, not recruiting
 
Locations

Investigative Site

Fort Wayne, United States, 46825

Status
Active, not recruiting
 
Locations

Investigative Site

Chandler, United States, 85224

Status
Active, not recruiting
 
Locations

Investigative Site

Arvada, United States, 80005

Status
Active, not recruiting
 
Locations

Investigative Site

Glendale, United States, 85306

Status
Active, not recruiting
 
Locations

Investigative Site

Córdoba, Spain, 14004

Status
Active, not recruiting
 
Locations

Investigative Site

Regina, Canada, S4P 0W5

Status
Completed
 
Locations

Investigative Site

HOOFDDORP, Netherlands, 2134 TM

Status
Completed
 
Locations

Investigative Site

AMSTERDAM, Netherlands, 1061 AE

Status
Completed
 
Locations

Investigative Site

NIEUWEGEIN, Netherlands, 3435 CM

Status
Active, not recruiting
 
Locations

Investigative Site

VELDHOVEN, Netherlands, 5504 DB

Status
Active, not recruiting
 
Locations

Investigative Site

ZWOLLE, Netherlands, 8025 AB

Status
Active, not recruiting
 
Locations

Investigative Site

Tiel, Netherlands, 4002 WP

Status
Active, not recruiting
 

Trial Design