Essure Transvaginal Ultrasound (TVU) Study

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.

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Key information

Conditions

Contraceptive Usage Behavior Contraception Behavior Reproductive Behavior

Age range

21 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Regina, Saskatchewan, Canada

About this study

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

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TVU

Device

Use of transvaginal ultrasound to determine location of micro-insert

Primary outcomes

Effectiveness

Time frame: Annually beginning at one year

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2023
First posted: Apr 1, 2011
Registry last updated: Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed