NCT01327105

Essure Transvaginal Ultrasound (TVU) Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 21 Years – 44 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraceptive Usage

Interventions

Type	Name	Description
DEVICE	TVU	Use of transvaginal ultrasound to determine location of micro-insert

Timeline

• Start date: 2011-05-17
• Primary completion: 2014-07-16
• Completion: 2023-07-04
• First posted: 2011-04-01
• Last updated: 2023-08-03

Locations

21 sites across 4 countries: United States, Canada, Netherlands, Spain

Regulatory

• FDA-regulated device study