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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: Completed Phase 3 study, sponsored by Mentor Worldwide.
NCT00753922 is a Phase 3 study that has completed, run by Mentor Worldwide. The registered enrollment target is 1,008 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.
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 |
What the finished NCT00753922 record still lists
NCT00753922 is an interventional study that assigns participants to a tested intervention. Its 1,008 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00753922's enrollment target sits among peer trials
1,008 295th of 2000 higher than 1,706 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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