Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Breast Reconstruction and Breast Augmentation, sponsored by Mentor Worldwide.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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 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 |
What the finished NCT01959880 record still lists
NCT01959880 is an interventional study that assigns participants to a tested intervention. Its 1,891 participants enrollment target places it among the larger protocols in the corpus, above the 289-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (554% higher).
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 a single indexed study location in 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.
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 NCT01959880's enrollment target sits among peer trials
1,891 1st of 18 higher than 18 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
-
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
RECRUITING · Phase 3
-
Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
COMPLETED · Phase 3
-
A Study on Pain After Breast Reconstruction
RECRUITING · NA
-
Melodi Matrix™ in Breast Reconstruction
RECRUITING · NA
-
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
RECRUITING · NA
-
Impact of Pectoral Versus Paravertebral Blocks on Pain and Physical Well-Being in Implant-Based Breast Reconstruction
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07308717 · 1,896 participants · Phase 4
Gabapentin And Breast Surgery Decision Architecture Randomization Trial (GABS-DART) Protocol
- NCT03729180 · 1,900 participants · NA
The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery
- NCT05712200 · 1,900 participants · Phase 3
Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
- NCT06929806 · 1,900 participants · Phase 3
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia