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Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
NCT00812097 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00812097
The ClinicalTrials.gov registry entry for NCT00812097 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 955 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mentor Worldwide, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00812097 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00812097?
The interventions under investigation include: Mentor Siltex® Contour Profile Gel Mammary Prosthesis (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00812097?
This trial is sponsored by Mentor Worldwide, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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