Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01327105 · ClinicalTrials.gov registry record · Phase 4
Essure Transvaginal Ultrasound (TVU) Study
A Phase 4 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 4
- Development phase
- 547
- Enrollment target
NCT01327105 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 547 participants.
The verdict
NCT01327105, a Phase 4 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 547 participants
- Enrollment target
Study 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.
Interventions
- DEVICE TVU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2011-05-17 |
| Est. Completion | 2023-07-04 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01327105
The ClinicalTrials.gov registry entry for NCT01327105 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TVU is the first listed.
NCT01327105 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01327105 about?
NCT01327105 is a clinical study titled "Essure Transvaginal Ultrasound (TVU) Study". 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...
What is the current status of trial NCT01327105?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 547 participants. The study started on 2011-05-17. Estimated completion is 2023-07-04.
What interventions are being tested in trial NCT01327105?
The interventions under investigation include: TVU (DEVICE).
Who is sponsoring clinical trial NCT01327105?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.