check_circleStudy Completed
Contraceptive Usage
Bayer Identifier:
16974
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Essure Transvaginal Ultrasound (TVU) Study
Trial 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.
The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective method of confirming micro-insert location.
Key Participants Requirements
Sex
FemaleAge
21 - 44 YearsTrial summary
Enrollment Goal
547Trial Dates
May 2011 - July 2023Phase
Phase 4Could I Receive a placebo
NoProducts
Essure (ESS305, BAY1454032)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Tucson, 85712, United States | |
Active, not recruiting | Columbus, 43231, United States | |
Active, not recruiting | Winston-Salem, 27103, United States | |
Active, not recruiting | Saginaw, 48604, United States | |
Active, not recruiting | Phoenix, 85032, United States | |
Active, not recruiting | Rochester, 55905, United States | |
Active, not recruiting | Houston, 77074, United States | |
Active, not recruiting | Asheville, 28801, United States | |
Active, not recruiting | Bronx, 10467, United States | |
Active, not recruiting | Fort Wayne, 46825, United States | |
Active, not recruiting | Chandler, 85224, United States | |
Active, not recruiting | Arvada, 80005, United States | |
Active, not recruiting | Glendale, 85306, United States | |
Completed | Córdoba, 14004, Spain | |
Completed | Regina, S4P 0W5, Canada | |
Completed | Hoofddorp, 2134 TM, Netherlands | |
Completed | AMSTERDAM, 1061 AE, Netherlands | |
Active, not recruiting | NIEUWEGEIN, 3435 CM, Netherlands | |
Active, not recruiting | VELDHOVEN, 5504 DB, Netherlands | |
Active, not recruiting | ZWOLLE, 8025 AB, Netherlands | |
Completed | Tiel, 4002 WP, Netherlands |
Primary Outcome
- EffectivenessRate of pregnancy at 1 and 10 years among subjects relying on Essure micro-inserts for birth control on the basis of the TVU/HSG algorithmdate_rangeTime Frame:Annually beginning at one yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DeviceTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1