Clinical trials: Breast Augmentation
Breast Augmentation
European New Texture Implant Clinical Experience With Round Breast Implants
The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.
- Trial name
- NCT01639742
- Testing
- New texture round breast implants
- Where
- 4 sites in Germany, Sweden and 1 more
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Augmentation, Mammoplasty
Evaluation of the Clinical Evolution of Breast Increase Using Prostheses
The breasts are paired, superficial organs with relative symmetry. They particularly characterize femininity as an erogenous area, in addition to playing an extremely important role in a woman's body aesthetics.
- Trial name
- NCT06079086
- Testing
- Breast Implants Lifesil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Lifesil
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
Surgical Scar, Breast Augmentation
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Evaluator-blinded study of the safety and performance of fractional radiofrequency (FRF) for the treatment of surgical scars following breast augmentation, abdominoplasty or facelift.
- Conditions
- Surgical Scar, Breast Augmentation, Abdominoplasty, Face Lift
- Trial name
- NCT03467724
- Testing
- Fractional Radiofrequency (FRF)
- Where
- Spain
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Breast Augmentation, Breast Reconstruction
A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants…
- Trial name
- NCT04261608
- Where
- 6 sites in China
- Volunteers
- 225 people
- Sponsor
- Allergan
Postoperative Pain
Observational Study to Assess Long-Term Follow-Up of Breast Augmentation Subjects
A history and physical focused on clinical sequelae of breast implant rupture was completed by patients to assess long-term clinical sequelae of SKY0402 and its relation to the silicon shell.
- Trial name
- NCT01076686
- Testing
- Questionnaire and Physical Exam
- Volunteers
- 94 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Breast Augmentation
Swedish Macrolane Registry
A Registry to monitor long term safety in female subjects after treatment with Macrolane VRF20 and/or MacrolaneT VRF30 in the breasts.
- Trial name
- NCT01145235
- Where
- Sweden
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
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 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
Postoperative Pain
Bupivacaine HCl PK and Safety in Augmentation Mammoplasty
This is a Phase 4, randomized, open-label study of bupivacaine HCl administered either by instillation into the surgical site or by injection into the surgical site in subjects undergoing bilateral submuscular augmentation…
- Trial name
- NCT03705065
- Testing
- Bupivacaine HCl
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Heron Therapeutics
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 Augmentation, Breast Reconstruction
Post Approval Continued Access Study of the MENTOR® Contour Profile Gel Breast Implant
The Contour Profile Gel Continued Access Study is designed to demonstrate safety 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-CA (NCT00811525)
- Testing
- Mentor Siltex® Contour Profile Gel Mammary Prosthesis
- Sponsor
- Mentor Worldwide, 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
Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III
Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast…
- Conditions
- Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV
- Trial name
- STANCE (NCT05945329)
- Testing
- GalaFLEX LITE™ Scaffold, Standard surgery
- Where
- 37 sites in United States
- Volunteers
- 250 people
- Sponsor
- C. R. Bard
Mammaplasty, Cicatrix
RN1001(Avotermin) in Scar Improvement Following Breast Augmentation
This will be a multi-centre, double-blind, within-subject, placebo controlled randomised trial in female subjects. All subjects will undergo bilateral breast augmentation surgery.
- Trial name
- NCT00436449
- Testing
- Avotermin
- Where
- 7 sites in United Kingdom
- Volunteers
- 63 people
- Sponsor
- Renovo
Breast Augmentation
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.
- Trial name
- NCT01146275
- Testing
- Radiologial breast examination
- Where
- 4 sites in Sweden
- Volunteers
- 6 people
- Sponsor
- Galderma R&D
Breast Augmentation and Breast Reconstruction, Mammaplasty
Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction
This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction.
- Conditions
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation
- Trial name
- NCT07623564
- Testing
- Mia Harmonization, Mia Scarless Lift, Mia Reconstruction
- Where
- Costa Rica
- Volunteers
- 60 people
- Sponsor
- Establishment Labs
Musculoskeletal Pain
Study to Evaluate EB-001 in Reducing Musculoskeletal Pain
To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants
- Trial name
- NCT03193593
- Testing
- EB-001
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Bonti, Inc.
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, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)