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Completed Phase 4 Interventional Accepts healthy volunteers

Essure Transvaginal Ultrasound (TVU) Study

ClinicalTrials.gov ID: NCT01327105

Public ClinicalTrials.gov record NCT01327105. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 7:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Use of Transvaginal Ultrasound to Confirm Essure® Micro-insert Placement in Women: Demonstration of Effectiveness

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01327105
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Bayer
Industry
Enrollment
547 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
21 Years to 44 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 17, 2011 (Actual)
Primary completion
Jul 16, 2014 (Actual)
Completion
Jul 4, 2023 (Actual)
Last update posted
Aug 3, 2023

2011 – 2023

United States locations

U.S. sites
13
U.S. states
9
U.S. cities
13
Facility City State ZIP Site status
Not listed Chandler Arizona 85224 —
Not listed Glendale Arizona 85306 —
Not listed Phoenix Arizona 85032 —
Not listed Tucson Arizona 85712 —
Not listed Arvada Colorado 80005 —
Not listed Fort Wayne Indiana 46825 —
Not listed Saginaw Michigan 48604 —
Not listed Rochester Minnesota 55905 —
Not listed The Bronx New York 10467 —
Not listed Asheville North Carolina 28801 —
Not listed Winston-Salem North Carolina 27103 —
Not listed Columbus Ohio 43231 —
Not listed Houston Texas 77074 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01327105, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 3, 2023 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01327105 live on ClinicalTrials.gov.

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