Clinical trials: Breast Implant
Aesthetic Breast Surgery, Breast Implants
Thirteen-Year Trends in Aesthetic Breast Implant Surgery
This prospective observational cohort study evaluated temporal trends in primary aesthetic breast augmentation, breast implant replacement, and definitive breast implant removal at IQ Interquirofanos in Medellín, Colombia.
- Trial name
- NCT07765953
- Testing
- Primary Aesthetic Breast Augmentation, Breast Implant Replacement, Definitive Breast Implant Removal
- Where
- Colombia
- Volunteers
- 22,642 people
- Sponsor
- Research Inc
Breast Augmentation
Mia® Clinical Study
This study will follow 100 women over 36 months (3 years) to evaluate how safe and effective a minimally invasive breast augmentation procedure is.
- Trial name
- NCT06792409
- Testing
- Minimally invasive breast augmentation procedure with a trans-axillary approach.
- Where
- Costa Rica
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Breast Reconstruction
Study of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction
The purpose of this study is to determine the safety and effectiveness of the Becker Expander/Breast Implant in women who are undergoing primary breast reconstruction.
- Trial name
- NCT00750685
- Testing
- Mentor Smooth Becker 50 Expander/Breast Implant
- Volunteers
- 315 people
- Sponsor
- Mentor Worldwide, LLC
Breast Augmentation, Breast Reconstruction
Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- CPG (NCT00812097)
- Testing
- Mentor Siltex® Contour Profile Gel Mammary Prosthesis
- Where
- United States
- Volunteers
- 955 people
- Sponsor
- Mentor Worldwide, LLC
Breast Augmentation
Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping
The purpose of this study is to determine how different types of breast implants contour to the chest wall.
- Trial name
- NCT01238601
- Volunteers
- 18 people
- Sponsor
- Ideal Implant Incorporated
Breast Implants
Study of the Safety and Effectiveness of Motiva Implants®
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
- Trial name
- NCT03579901
- Testing
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Where
- 29 sites in United States, Germany and 1 more
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Breast Augmentation
Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery.
- Trial name
- NCT02571751
- Testing
- UNIGEL Silicone Gel-Filled Breast Implant
- Where
- South Korea
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Sewoon Medical Co., Ltd
Breast Augmentation
Long-Term Effectiveness of the Motiva Implants® Round and Round Ergonomix
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.
- Trial name
- MIRO (NCT05449587)
- Testing
- MRI and PRO
- Where
- 2 sites in Costa Rica
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Breast Reconstruction
Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction
The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction.
- Trial name
- Neo-Matrix (NCT07480421)
- Testing
- Acellular matrix
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Silimed Industria de Implantes Ltda
Breast Implant Revision, Breast Augmentation Complications
Scaffold-guided Breast Implant Revision and Primary Breast Augmentation Surgery
The objective of the clinical investigation is to demonstrate safety and clinical performance of the absorbable polycaprolactone (PCL) breast scaffold combined with autologous fat grafting (AFG) for primary breast augmentation…
- Conditions
- Breast Implant Revision, Breast Augmentation Complications, Primary Breast Augmentation Surgery
- Trial name
- NCT07367698
- Testing
- Implantation of the PCL Breast scaffold with autologous fat grafting
- Where
- 3 sites in Australia
- Volunteers
- 87 people
- Sponsor
- BellaSeno Pty Ltd
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Reconstruction
Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
Mentor is undertaking a five-year prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses.
- Trial name
- Adjunct (NCT00948948)
- Testing
- Silicone Gel-Filled Mammary Prostheses
- Where
- United States
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction, Breast Augmentation
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- NCT00753922
- Testing
- Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
- Where
- United States
- Volunteers
- 1,008 people
- Sponsor
- Mentor Worldwide, LLC
Breast Implants
Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants
The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation…
- Trial name
- NCT00858052
- Testing
- Saline-filled breast implant [IDEAL IMPLANT (R)]
- Where
- 24 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Ideal Implant Incorporated
Breast Cancer
Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging.
- Trial name
- NCT02155075
- Testing
- MIRA device imaging
- Where
- Israel
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Real Imaging Ltd.
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
Breast Implant Rupture, Breast Implant; Complications
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT
- Trial name
- ELEGANT (NCT05987475)
- Testing
- Breast reconstruction
- Where
- France
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Euromi Biosciences
Primary Breast Augmentation, Primary Breast Reconstruction
Memory Gel and Shape Combined Cohort
The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or…
- Conditions
- Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction
- Trial name
- Glow (NCT02919592)
- Testing
- MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery
- Where
- 78 sites in United States
- Volunteers
- 3,603 people
- Sponsor
- Mentor Worldwide, LLC
Breast Diseases
REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy.
- Trial name
- NCT05533099
- Testing
- Observational study
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Tensive SRL