Essure Transvaginal Ultrasound (TVU) Study
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.
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
- Enrollment
- 547 participants
Conditions and interventions
Conditions
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 16, 2011
- Primary completion
- Jul 15, 2014
- Completion
- Jul 3, 2023
- Last update posted
- Aug 2, 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 2, 2023 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01327105 live on ClinicalTrials.gov.