Study Completed

Contraceptive Usage

Bayer Identifier:

16974

ClinicalTrials.gov Identifier:

NCT01327105

EudraCT Number:

Not Available

EU CT Number:

Not Available

Essure Transvaginal Ultrasound (TVU) Study

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.

Key Participants Requirements

Sex

Female

Age

21 - 44 Years

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

May 2011 - July 2023

Phase

Phase 4

Could I Receive a placebo

Products

Essure (ESS305, BAY1454032)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Active, not recruiting		Tucson, 85712, United States
Active, not recruiting		Columbus, 43231, United States
Active, not recruiting		Winston-Salem, 27103, United States
Active, not recruiting		Saginaw, 48604, United States
Active, not recruiting		Phoenix, 85032, United States
Active, not recruiting		Rochester, 55905, United States
Active, not recruiting		Houston, 77074, United States
Active, not recruiting		Asheville, 28801, United States
Active, not recruiting		Bronx, 10467, United States
Active, not recruiting		Fort Wayne, 46825, United States
Active, not recruiting		Chandler, 85224, United States
Active, not recruiting		Arvada, 80005, United States
Active, not recruiting		Glendale, 85306, United States
Completed		Córdoba, 14004, Spain
Completed		Regina, S4P 0W5, Canada
Completed		Hoofddorp, 2134 TM, Netherlands
Completed		AMSTERDAM, 1061 AE, Netherlands
Active, not recruiting		NIEUWEGEIN, 3435 CM, Netherlands
Active, not recruiting		VELDHOVEN, 5504 DB, Netherlands
Active, not recruiting		ZWOLLE, 8025 AB, Netherlands
Completed		Tiel, 4002 WP, Netherlands

Primary Outcome

Effectiveness
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
Time Frame:
Annually beginning at one year
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Device

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms