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Essure Transvaginal Ultrasound (TVU) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327105
Recruitment Status : Active, not recruiting
First Posted : April 1, 2011
Last Update Posted : November 9, 2022
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Contraceptive Usage Device: TVU Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 547 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Transvaginal Ultrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of Effectiveness
Actual Study Start Date : May 17, 2011
Actual Primary Completion Date : July 16, 2014
Estimated Study Completion Date : July 28, 2023

Arm Intervention/treatment
Experimental: TVU Device: TVU
Use of transvaginal ultrasound to determine location of micro-insert

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327105

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United States, Arizona
Chandler, Arizona, United States, 85224
Glendale, Arizona, United States, 85306
Phoenix, Arizona, United States, 85032
Tucson, Arizona, United States, 85712
United States, Colorado
Arvada, Colorado, United States, 80005
United States, Indiana
Fort Wayne, Indiana, United States, 46825
United States, Michigan
Saginaw, Michigan, United States, 48604
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
Bronx, New York, United States, 10467
United States, North Carolina
Asheville, North Carolina, United States, 28801
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Columbus, Ohio, United States, 43231
United States, Texas
Houston, Texas, United States, 77074
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4P 0W5
Amsterdam, Netherlands, 1061 AE
Hoofddorp, Netherlands, 2134 TM
Nieuwegein, Netherlands, 3435 CM
Tiel, Netherlands, 4002 WP
Veldhoven, Netherlands, 5504 DB
Zwolle, Netherlands, 8025 AB
Córdoba, Spain, 14004
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01327105    
Other Study ID Numbers: 16974
ESS-TVU ( Other Identifier: Company internal )
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: November 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes