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NCT01286870 · ClinicalTrials.gov registry record · Phase 4
Becker Continued Access Study
A Phase 4 study, sponsored by Mentor Worldwide.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT01286870 is a Phase 4 study that was terminated before completion, run by Mentor Worldwide. The registered enrollment target is 11 participants.
The verdict
NCT01286870, a Phase 4 study, was terminated before completion, sponsored by Mentor Worldwide.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device. Up to 12 patients per month at sites across the United States will be enrolled in this research study. These patients will be implanted with the Becker 25 or Becker 50 Expander/Breast implant and monitored for 10 years for safety.
Interventions
- DEVICE Mentor Becker 25 Expander/Breast Implant
- DEVICE Mentor Becker 50 Expander/Breast Implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2009-06-01 |
| Est. Completion | 2014-03-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01286870
The ClinicalTrials.gov registry entry for NCT01286870 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mentor Worldwide, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mentor Becker 25 Expander/Breast Implant is the first listed.
NCT01286870 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01286870 about?
NCT01286870 is a clinical study titled "Becker Continued Access Study". While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device. Up to 12 patients per month at sites across the United States will be enrolled in th...
What is the current status of trial NCT01286870?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2009-06-01. Estimated completion is 2014-03-04.
What interventions are being tested in trial NCT01286870?
The interventions under investigation include: Mentor Becker 25 Expander/Breast Implant (DEVICE), Mentor Becker 50 Expander/Breast Implant (DEVICE).
Who is sponsoring clinical trial NCT01286870?
This trial is sponsored by Mentor Worldwide, which has 11 total clinical trials registered on ClinicalTrials.gov.
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