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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.

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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.

Interventions

  • DEVICE The Contour Profile Gel (CPG) breast implants

Study Locations (1)

California

  • Mentor Worldwide LLC - Santa Barbara

Trial Details

FieldValue
Enrollment Target 1,891 participants
Start Date 2013-08
Est. Completion 2015-06
Phase Phase 3

Sponsor

Mentor Worldwide

11 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.