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NCT00753922 · ClinicalTrials.gov registry record · Phase 3
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
A Phase 3 study, sponsored by Mentor Worldwide.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,008
- Enrollment target
NCT00753922 is a Phase 3 study that has completed, run by Mentor Worldwide. The registered enrollment target is 1,008 participants.
The verdict
NCT00753922, a Phase 3 study, has completed, sponsored by Mentor Worldwide.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,008 participants
- Enrollment target
Study Summary
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infection will be collected, and used to help determine device safety. Approximately 1000 patients at centers across the United States will be enrolled in this research study. These patients will be implanted with silicone breast prostheses and monitored for 10 years to collect information on risks associated with the implant surgery as well as changes in the way these patients feel about themselves.
Interventions
- DEVICE Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,008 participants |
| Start Date | 2000-09 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00753922
The ClinicalTrials.gov registry entry for NCT00753922 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,008 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 1 intervention - of which Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface is the first listed.
NCT00753922 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00753922 about?
NCT00753922 is a clinical study titled "Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses". The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture, and infect...
What is the current status of trial NCT00753922?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,008 participants. The study started on 2000-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00753922?
The interventions under investigation include: Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface (DEVICE).
Who is sponsoring clinical trial NCT00753922?
This trial is sponsored by Mentor Worldwide, which has 11 total clinical trials registered on ClinicalTrials.gov.
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