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NCT01959880 · ClinicalTrials.gov registry record · Phase 3
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
A Phase 3 study of Breast Reconstruction and Breast Augmentation, sponsored by Mentor Worldwide.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,891
- Enrollment target
- 1
- Study location
NCT01959880 is a Phase 3 study of Breast Reconstruction and Breast Augmentation that has completed, run by Mentor Worldwide. The registered enrollment target is 1,891 participants, above the 289-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (554% higher). The trial reports 1 study location across 1 state.
The verdict
NCT01959880, a Phase 3 study of Breast Reconstruction and Breast Augmentation, has completed, sponsored by Mentor Worldwide.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,891 participants
- Enrollment target
- 1
- Study location
Study Summary
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants 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 determine device safety.
Conditions Studied
Interventions
- DEVICE The Contour Profile Gel (CPG) breast implants
Study Locations (1)
California
- Mentor Worldwide LLC - Santa Barbara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,891 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01959880
The ClinicalTrials.gov registry entry for NCT01959880 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,891 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 289-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (554% 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 The Contour Profile Gel (CPG) breast implants is the first listed.
NCT01959880 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01959880 about?
NCT01959880 is a clinical study titled "CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)". The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision. Safety information on the rate of capsular contracture, rupture and infection wi...
What is the current status of trial NCT01959880?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,891 participants. The study started on 2013-08. Estimated completion is 2015-06.
What conditions does trial NCT01959880 study?
This clinical trial studies the following conditions: Breast Reconstruction, Breast Augmentation, Breast Revision.
What interventions are being tested in trial NCT01959880?
The interventions under investigation include: The Contour Profile Gel (CPG) breast implants (DEVICE).
Who is sponsoring clinical trial NCT01959880?
This trial is sponsored by Mentor Worldwide, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01959880 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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