NCT01327105

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2011

Longer than P75 for phase_4

Geographic Reach
4 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2014

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

3.2 years

First QC Date

March 30, 2011

Last Update Submit

August 2, 2023

Conditions

Contraceptive Usage

Outcome Measures

Primary Outcomes (1)

  • 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

    Annually beginning at one year

Study Arms (1)

TVU

EXPERIMENTAL
Device: TVU

Interventions

TVUDEVICE

Use of transvaginal ultrasound to determine location of micro-insert

TVU

Eligibility Criteria

Age21 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Chandler, Arizona, 85224, United States

Location

Unknown Facility

Glendale, Arizona, 85306, United States

Location

Unknown Facility

Phoenix, Arizona, 85032, United States

Location

Unknown Facility

Tucson, Arizona, 85712, United States

Location

Unknown Facility

Arvada, Colorado, 80005, United States

Location

Unknown Facility

Fort Wayne, Indiana, 46825, United States

Location

Unknown Facility

Saginaw, Michigan, 48604, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

The Bronx, New York, 10467, United States

Location

Unknown Facility

Asheville, North Carolina, 28801, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Columbus, Ohio, 43231, United States

Location

Unknown Facility

Houston, Texas, 77074, United States

Location

Unknown Facility

Regina, Saskatchewan, S4P 0W5, Canada

Location

Unknown Facility

Amsterdam, 1061 AE, Netherlands

Location

Unknown Facility

Hoofddorp, 2134 TM, Netherlands

Location

Unknown Facility

Nieuwegein, 3435 CM, Netherlands

Location

Unknown Facility

Tiel, 4002 WP, Netherlands

Location

Unknown Facility

Veldhoven, 5504 DB, Netherlands

Location

Unknown Facility

Zwolle, 8025 AB, Netherlands

Location

Unknown Facility

Córdoba, 14004, Spain

Location

Related Publications (1)

  • Vleugels M, Cheng RF, Goldstein J, Bangerter K, Connor V. Algorithm of Transvaginal Ultrasound and/or Hysterosalpingogram for Confirmation Testing at 3 Months after Essure Placement. J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1128-1135. doi: 10.1016/j.jmig.2017.06.021. Epub 2017 Jun 29.

    PMID: 28669895DERIVED

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 1, 2011

Study Start

May 17, 2011

Primary Completion

July 16, 2014

Study Completion

July 4, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Locations

US(13)CA(1)NL(6)ES(1)