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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: Completed Phase 4 study, sponsored by Bayer.
NCT01327105 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 547 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Rate of pregnancy at 1 and 10 years among subjects relying on Essure micro-inserts for birth control on the basis of the TVU/HSG algorithm
Interventions
- DEVICE TVU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2011-05-17 |
| Est. Completion | 2023-07-04 |
| Phase | Phase 4 |
What the finished NCT01327105 record still lists
NCT01327105 is an interventional study that assigns participants to a tested intervention. The registered 547 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which TVU is the first listed.
NCT01327105 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01327105's enrollment target sits among peer trials
547 153rd of 2000 higher than 1,847 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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