Essure Transvaginal Ultrasound (TVU) Study

Bayer

Status and phase

Completed

Phase 4

Conditions

Contraceptive Usage

Treatments

Device: TVU

Study type

Interventional

Funder types

Industry

Identifiers

NCT01327105

ESS-TVU (Other Identifier)

16974

Details and patient eligibility

About

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.

Full 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.

Enrollment

547 patients

Sex

Female

Ages

21 to 44 years old

Volunteers

Accepts Healthy Volunteers

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