Breast Augmentation Clinical Trial
Official title:
Study of the Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix in Primary and Revision Breast Augmentation
Post-marketing surveillance study to demonstrate the silent rupture rate and satisfaction of patients who underwent a primary and revision breast augmentation surgery with Motiva Implants®, 3 to 10 years before enrollment.
Single-arm, multicenter study with a minimum of 160 subjects who underwent Breast Implant surgery from 3-10 years postoperatively. Following IRB / EC approval - and if applicable Competent Authority approval - Magnetic Resonance Imaging (MRI) and Patient-Reported Outcome (PRO) with the validated BREAST-Q will be collected at a single time point for all enrolled subjects. MRI data will be used for the analysis of silent rupture, and BREAST-Q Postoperative Augmentation module scales to record patients for satisfaction. Two styles of Motiva Implants® will be used for this study: - Motiva Implants® Silicone Gel-Filled Breast Implants, SmoothSilk® Round (referred to as "Motiva Implants® Round ProgressiveGel® Plus", or "Round") - Motiva Implants® Silicone Gel-Filled Breast Implants, SmoothSilk® Round Ergonomix® (referred to as "Motiva Implants® Ergonomix® Round ProgressiveGel® Ultima®", or "Round Ergonomix"). Henceforth, these devices will generally be referenced as "Motiva Implants®." ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06013514 -
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
|
||
| Completed |
NCT00753922 -
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
|
Phase 3 | |
| Completed |
NCT01945463 -
The Effect of Breast Augmentation on the Quality of Echocardiography Test
|
N/A | |
| Completed |
NCT02302001 -
Effects of Jet Hydro Dissection in Breast Augmentation Postoperative Pain
|
N/A | |
| Completed |
NCT00905645 -
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
|
N/A | |
| Completed |
NCT00756652 -
Mentor MemoryGel Post-Approval Study
|
||
| Terminated |
NCT01870869 -
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
|
N/A | |
| Completed |
NCT00684749 -
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
|
N/A | |
| Active, not recruiting |
NCT06079086 -
Evaluation of the Clinical Evolution of Breast Increase Using Prostheses
|
N/A | |
| Active, not recruiting |
NCT03386682 -
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
|
N/A | |
| Completed |
NCT01146275 -
A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106
|
N/A | |
| Completed |
NCT00663156 -
A Prospective Study of Autologous Fat Grafting for Breast Augmentation
|
N/A | |
| Completed |
NCT00605670 -
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery
|
N/A | |
| Completed |
NCT01639755 -
European New Texture Implant Clinical Experience With Shaped Breast Implants
|
Phase 4 | |
| Completed |
NCT01639742 -
European New Texture Implant Clinical Experience With Round Breast Implants
|
N/A | |
| Completed |
NCT04036487 -
Effects of General Anesthesia on Quality of Recovery After Transaxillary Endoscopic Breast Augmentation
|
N/A | |
| Completed |
NCT01238601 -
Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping
|
N/A | |
| Completed |
NCT03467724 -
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
|
N/A | |
| Completed |
NCT02235285 -
Asian Outcomes of Primary Breast Augmentation
|
N/A | |
| Completed |
NCT00689871 -
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
|
N/A |