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NCT01948882 · ClinicalTrials.gov registry record · NA
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
A NA study, sponsored by Bayer.
- Completed
- Registry status
- NA
- Development phase
- 660
- Enrollment target
NCT01948882: Completed NA study, sponsored by Bayer.
NCT01948882 is a NA study that has completed, run by Bayer. The registered enrollment target is 660 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01948882, a NA study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- NA
- Development phase
- 660 participants
- Enrollment target
Study Summary
The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing pregnancy. The Essure ESS505 System includes a design modification that will be studied to determine if it provides immediate birth control, thereby removing the three months waiting period required for the commercially available Essure System Model 305 to be effective.
Primary Outcome
Evaluated after 6000 women-months of reliance have been accumulated
Interventions
- DEVICE ESS505 (BAY1454033)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2024-09-12 |
| Phase | NA |
What the finished NCT01948882 record still lists
NCT01948882 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which ESS505 (BAY1454033) is the first listed.
NCT01948882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01948882 about?
NCT01948882 is a clinical study titled "Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women". The Essure System is indicated for women who desire non-incisional permanent birth control (female sterilization) by occlusion of the fallopian tubes. The objective of the study is to evaluate the safety and effectiveness of the Essure System (Model ESS505) for permanent birth control in preventing ...
What is the current status of trial NCT01948882?
This trial is currently completed. It is a NA study. The enrollment target is 660 participants. The study started on 2013-09-30. Estimated completion is 2024-09-12.
What interventions are being tested in trial NCT01948882?
The interventions under investigation include: ESS505 (BAY1454033) (DEVICE).
Who is sponsoring clinical trial NCT01948882?
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 NCT01948882's enrollment target sits among peer trials
660 155th of 2000 higher than 1,845 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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