NCT01327105

Essure Transvaginal Ultrasound (TVU) Study

Completed Phase 4 Last updated 3 August 2023

What this trial tests

Phase 4 trial testing TVU in Contraceptive Usage in 547 participants. Completed in 4 July 2023.

Timeline

17 May 2011

Primary endpoint
16 July 2014

4 July 2023

Quick facts

Lead sponsor	Bayer
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	547
Start date	17 May 2011
Primary completion	16 July 2014
Estimated completion	4 July 2023
Sites	21 locations across Netherlands, Canada, United States, Spain

Drugs / interventions tested

• TVU

Conditions studied

• Contraceptive Usage — all drugs for Contraceptive Usage →

Sponsor

Bayer — full company profile →

Who can join

Adults 21 to 44, female only, with Contraceptive Usage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement.
   Vleugels M, Cheng RF, Goldstein J, Bangerter K, et al · · 2017 · cited 3× · PMID 28669895 · DOI 10.1016/j.jmig.2017.06.021