Essure Transvaginal Ultrasound (TVU) Study

NCT ID: NCT01327105

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 547 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-17
• Study Completion Date: 2023-07-04

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.

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.

Conditions

Contraceptive Usage

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TVU

Group Type: EXPERIMENTAL

TVU

Intervention Type: DEVICE

Use of transvaginal ultrasound to determine location of micro-insert

Interventions

TVU

Use of transvaginal ultrasound to determine location of micro-insert

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Chandler, Arizona, United States

Glendale, Arizona, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Arvada, Colorado, United States

Fort Wayne, Indiana, United States

Saginaw, Michigan, United States

Rochester, Minnesota, United States

The Bronx, New York, United States

Asheville, North Carolina, United States

Winston-Salem, North Carolina, United States

Columbus, Ohio, United States

Houston, Texas, United States

Regina, Saskatchewan, Canada

Amsterdam, , Netherlands

Hoofddorp, , Netherlands

Nieuwegein, , Netherlands

Tiel, , Netherlands

Veldhoven, , Netherlands

Zwolle, , Netherlands

Córdoba, , Spain

Countries

United States; Canada; Netherlands; Spain

References

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.

Reference Type: DERIVED

PMID: 28669895 (View on PubMed)

Other Identifiers

ESS-TVU

Identifier Type: OTHER

Identifier Source: secondary_id

16974

Identifier Type: -

Identifier Source: org_study_id