Clinical trials: Primary Breast Augmentation
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 Implantation
Retrospective Study of Incidence and Etiology of Reoperation After Primary Augmentation With Natrelle® Breast Implants
Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)
- Trial name
- RANBI (NCT02132572)
- Testing
- BIOCELL™ Textured 410 Implant
- Where
- 5 sites in France, Germany and 3 more
- Volunteers
- 201 people
- Sponsor
- Allergan
Hypomastia, Primary Breast Augmentation
3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery
The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery.
- Trial name
- NCT01964105
- Testing
- 3D Imaging
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
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, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction, Safety and Performance
- Trial name
- STEPS S (NCT05345821)
- Where
- Brazil
- Volunteers
- 384 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
Breast Augmentation, Breast Revision-Augmentation
Post Market Clinical Experience Study of Sientra 207 Breast Implants
A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants
- Trial name
- NCT02905617
- Testing
- Sientra 207 Silicone Gel Breast Implant
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
Breast Augmentation
Asian Outcomes of Primary Breast Augmentation
In 162 Asian patients, primary breast augmentations were performed by a single surgeon during 5 years. The purpose of this study evaluates Asian outcomes in primary breast augmentation using single antibiotic breast irrigation by…
- Trial name
- BA (NCT02235285)
- Testing
- primary breast augmentation
- Where
- South Korea
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Winners Clinic
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 Implantation
Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants
This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.
- Trial name
- RANBI-I (NCT02438332)
- Testing
- Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants, Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants, Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants
- Where
- 17 sites in Canada
- Volunteers
- 330 people
- Sponsor
- Allergan
Breast Implant
Motiva Implants® Post-Approval Study
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
- Trial name
- Motiva PAS (NCT06938399)
- Testing
- Silicone gel-filled breast implants - Motiva Implants®, Aesthetic Surgery
- Where
- 33 sites in United States
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Surgical Site Infection, Capsular Contracture Associated With Breast Implant
Postoperative Antibiotics Following Primary and Secondary Breast Augmentation
Postoperative antibiotics are routinely used for implant-based breast augmentation at the investigators' institution. From 2017-2019, the investigators' institution has conducted approximately 270 primary and secondary breast…
- Conditions
- Surgical Site Infection, Capsular Contracture Associated With Breast Implant, Antibiotic Resistant Infection, Antibiotic Side Effect
- Trial name
- NCT04834310
- Testing
- Cefazolin, Cephalexin
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Bilateral Breast Augmentation
Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation
The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast…
- Trial name
- EMMA (NCT05336526)
- Testing
- ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants
- Where
- 6 sites in France
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
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
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 Implant; Complications, Quality of Life
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants
The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface.
- Conditions
- Breast Implant; Complications, Quality of Life, Satisfaction
- Trial name
- STEPS A (NCT03356132)
- Testing
- Silimed® Textured Silicone Gel-Filled Breast Implant, Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant
- Where
- Brazil
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
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
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
Plastic Surgery
Usefullness of Peri-operative Tranexamic Acid in Primary Breast Augmentation With Implants.
Tranexamic acid (TXA), as an antifibrinolytic agent, has shown a tremendous interest in surgery by reducing blood loss ; but only few articles have been reported in the plastic surgery scope.
- Trial name
- DRAINAGE (NCT03364569)
- Testing
- Tranexamic acid
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Hôpital NOVO
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
Augmentation, Augmentation Revision
Spectra Breast Implant Study
The purpose of this study is to demonstrate safety and effectiveness of Mentor's Spectra/Becker 80 Adjustable Breast Implants in women who are undergoing primary or revision breast augmentation.
- Conditions
- Augmentation, Augmentation Revision, General Breast Enlargement, Post-lactational Involution
- Trial name
- NCT00981266
- Testing
- Mentor Spectra/Becker 80 Breast Implant
- Where
- United States
- Sponsor
- Mentor Worldwide, LLC