check_circleStudy Completed
Contraceptive Usage
Bayer Identifier:infoA unique number for a trial given by Bayer.
16974
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
547The overall number of participants needed for a trial.
Trial Dates info
May 2011 - July 2023Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 4A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Essure (ESS305, BAY1454032)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
YesA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where 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 OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DeviceAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Open Label“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Single Group AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
1A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.