Breast Augmentation Clinical Trial
Official title:
A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106
Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had Macrolane deposits in the breast when the last study visit was performed. An additional follow up visit is planned to follow duration and safety of the former formulation of Macrolane that was used in the Pilot study (CTN 31GB0106).
All subjects included in a Pilot study between 2002-2003 (CTN 31GB0106) are offered to take part in a seven year safety follow up after the initial injection of the former formulation of Macrolane into the breasts. The study will not involve any additional treatments. The follow up will include relevant medical history, weight, breast examination, ultrasound and mammography to determine if there are/have been any safety issues since the final study visit in the Pilot study (CTN 31GB0106), as well as a comprehensive MRI investigation to assess the breast structure and determine if there are still deposits of Macrolane in the breast. ;
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 | |
Recruiting |
NCT05449587 -
Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
|
||
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 |
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 |
NCT01639742 -
European New Texture Implant Clinical Experience With Round Breast Implants
|
N/A | |
Completed |
NCT01639755 -
European New Texture Implant Clinical Experience With Shaped Breast Implants
|
Phase 4 | |
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 |