Essure Transvaginal Ultrasound (TVU) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01327105
First received: March 30, 2011
Last updated: May 13, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Contraceptive Usage
Device: TVU
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Transvaginal Ultrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of Effectiveness

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: Annually beginning at one year ] [ Designated as safety issue: No ]
    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


Enrollment: 582
Study Start Date: May 2011
Estimated Study Completion Date: July 2023
Estimated Primary Completion Date: July 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TVU Device: TVU
Use of transvaginal ultrasound to determine location of micro-insert

Detailed Description:

This study has previously been posted by Conceptus, Inc. (US).

After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.

  Eligibility

Ages Eligible for Study:   21 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327105

Locations
United States, Arizona
Chandler, Arizona, United States, 85224
Glendale, Arizona, United States, 85304
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
Netherlands
Amsterdam, Netherlands, 1061 AE
Hoofddorp, Netherlands, 2134 TM
Nieuwegein, Netherlands, 3435 CM
Tiel, Netherlands, 4002 WP
Veldhoven, Netherlands, 5504 DB
Zwolle, Netherlands, 8025 AB
Spain
Córdoba, Spain, 14004
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01327105     History of Changes
Other Study ID Numbers: 16974, ESS-TVU
Study First Received: March 30, 2011
Last Updated: May 13, 2014
Health Authority: Canada: Health Canada
Netherlands: Independent Ethics Committee
Spain: Ethics Committee
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 26, 2014