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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 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.
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.
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, categorized as Phase 3. The registered enrollment target is 955 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 341-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (180% higher). The listed sponsor is Mentor Worldwide, which has 11 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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