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NCT00812097 · ClinicalTrials.gov registry record · Phase 3
Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
A Phase 3 study of Breast Reconstruction and Breast Augmentation, sponsored by Mentor Worldwide.
- Completed
- Registry status
- Phase 3
- Development phase
- 955
- Enrollment target
- 1
- Study location
NCT00812097: Completed Phase 3 study of Breast Reconstruction and Breast Augmentation, sponsored by Mentor Worldwide.
NCT00812097 is a Phase 3 study of Breast Reconstruction and Breast Augmentation that has completed, run by Mentor Worldwide. The registered enrollment target is 955 participants, above the 341-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (180% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00812097, a Phase 3 study of Breast Reconstruction and Breast Augmentation, has completed, sponsored by Mentor Worldwide.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 955 participants
- Enrollment target
- 1
- Study location
Study Summary
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's 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 approximately 60 medical centers across the United States were enrolled in this research study. These patients were implanted with silicone breast prostheses and will be 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.
Conditions Studied
Interventions
- DEVICE Mentor Siltex® Contour Profile Gel Mammary Prosthesis
Study Locations (1)
California
- Mentor Worldwide, LLC - Santa Barbara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 955 participants |
| Start Date | 2002-02 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT00812097 record still lists
NCT00812097 is an interventional study that assigns participants to a tested intervention. The registered 955 participants enrollment target is mid-sized for trials with a published cap, above the 341-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (180% higher).
The record links to 3 conditions, with Breast Reconstruction appearing as the primary indexed condition, and to 1 intervention - of which Mentor Siltex® Contour Profile Gel Mammary Prosthesis is the first listed.
NCT00812097 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00812097 about?
NCT00812097 is a clinical study titled "Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial". The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's 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, an...
What is the current status of trial NCT00812097?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 955 participants. The study started on 2002-02. Estimated completion is 2014-10.
What conditions does trial NCT00812097 study?
This clinical trial studies the following conditions: Breast Reconstruction, Breast Augmentation, Breast Revision.
What interventions are being tested in trial NCT00812097?
The interventions under investigation include: Mentor Siltex® Contour Profile Gel Mammary Prosthesis (DEVICE).
Who is sponsoring clinical trial NCT00812097?
This trial is sponsored by Mentor Worldwide, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00812097 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Reconstruction
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00812097's enrollment target sits among peer trials
955 2nd of 18 the highest of 18 other Breast Reconstruction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Reconstruction 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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