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NCT01853605 · ClinicalTrials.gov registry record · NA
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
A NA study, sponsored by Allergan.
- Terminated
- Registry status
- NA
- Development phase
- 3,811
- Enrollment target
NCT01853605: Clinical Trial NA study, sponsored by Allergan.
NCT01853605 is a NA study that was terminated before completion, run by Allergan. The registered enrollment target is 3,811 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (171% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01853605, a NA study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- NA
- Development phase
- 3,811 participants
- Enrollment target
Study Summary
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
Primary Outcome
Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.
Interventions
- DEVICE Anatomically shaped silicone gel-filled breast implants
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,811 participants |
| Start Date | 2003-04 |
| Est. Completion | 2014-08 |
| Phase | NA |
Why NCT01853605 stopped before completion
NCT01853605 is an interventional study that assigns participants to a tested intervention. Its 3,811 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (171% higher).
The record links to 0 conditions, and to 1 intervention - of which Anatomically shaped silicone gel-filled breast implants is the first listed.
NCT01853605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01853605 about?
NCT01853605 is a clinical study titled "NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study". Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
What is the current status of trial NCT01853605?
This trial is currently terminated. It is a NA study. The enrollment target is 3,811 participants. The study started on 2003-04. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01853605?
The interventions under investigation include: Anatomically shaped silicone gel-filled breast implants (DEVICE).
Who is sponsoring clinical trial NCT01853605?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01853605's enrollment target sits among peer trials
3,811 36th of 2000 higher than 1,965 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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