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Essure Transvaginal Ultrasound (TVU) Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Conceptus, Inc.
ClinicalTrials.gov Identifier:
NCT01327105
First received: March 30, 2011
Last updated: April 4, 2012
Last verified: February 2012
History of Changes
  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 Conceptus, Inc.:

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


Estimated Enrollment: 600
Study Start Date: July 2011
Estimated Primary Completion Date: January 2014 (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

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who are 21 to 40 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327105

Locations
United States, Florida
Cleveland Clinic
Weston, Florida, United States, 33331
Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
Conceptus, Inc.
Investigators
Principal Investigator: Viviane Connor The Cleveland Clinic
Principal Investigator: Michel Vleugels St. Antonius Hospital
  More Information

No publications provided

Responsible Party: Conceptus, Inc.
ClinicalTrials.gov Identifier: NCT01327105     History of Changes
Other Study ID Numbers: ESS-TVU
Study First Received: March 30, 2011
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration
Spain: Ethics Committee
Netherlands: Independent Ethics Committee
United Kingdom: Research Ethics Committee
Canada: Health Canada

ClinicalTrials.gov processed this record on May 21, 2013