Clinical trials: Breast Augmentation
Atrophy of Breast
Efficacy and Safety Study of EVERA to Augment Small Breast
Expected Total Number of Subjects Level of significance, alfa 0.05 Power 0.80 Mean difference between two treatments is assumed 35 Standard Deviation is assumed 35. Follow-up loss is assumed 20% N=34(each group:17)
- Trial name
- NCT02009137
- Testing
- EVERA, ESTES
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
Brain Cancer, Breast Cancer
Study of Health Effects of Cosmetic Breast Augmentation
This study will examine long-term health effects of cosmetic breast augmentation (enlargement) with silicone gel breast implants.
- Conditions
- Brain Cancer, Breast Cancer, Lung Cancer, Suicide
- Trial name
- NCT00342953
- Where
- United States
- Volunteers
- 17,424 people
- Sponsor
- National Cancer Institute (NCI)
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 Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)
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)
Breast Augmentation, Mammaplasty
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population.
- Trial name
- NCT06510205
- Testing
- Mentor Breast implants
- Where
- 4 sites in China
- Volunteers
- 6,111 people
- Sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
Breast Augmentation, Breast Reconstruction
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
- Trial name
- EMMIE (NCT03386682)
- Testing
- ESTYME® MATRIX Breast Implants
- Where
- 8 sites in France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
Postoperative Pain After Breast Augmentation Surgery, Postoperative Analgesia
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
This randomized, controlled clinical study will evaluate the effect of an ultrasound-guided PECS II block on postoperative pain control in patients undergoing elective augmentation mammoplasty.
- Trial name
- NCT07879053
- Testing
- Ultrasound-Guided PECS II Block, Standard multimodal analgesia
- Volunteers
- 50 people
- Sponsor
- Ergun Gunduz
Pain, Postoperative
PECS I Block for Breast Subpectoral Implant Surgery
Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I…
- Trial name
- NCT02849236
- Testing
- Ropivacaine (PECS bloc)
- Where
- France
- Volunteers
- 56 people
- Sponsor
- University Hospital, Lille
Pain, Acute, Nausea
Enhanced Recovery Strategies in Elective Breast Surgery
Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return…
- Conditions
- Pain, Acute, Nausea, Vomiting, Postoperative, Opioid Use
- Trial name
- NCT03187080
- Testing
- Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline, Enhanced recovery after breast surgery (ERABS) strategies, Paravertebral block using local anesthetic
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
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 Implant Malposition, Breast Implant Rotation
Prospective Two-Year Cohort Study of Surgical and Implant Predictors of Breast Implant Displacement and Rotation After Aesthetic Augmentation
This prospective inception cohort will follow women for ten years after primary or revision aesthetic breast implantation. Pocket plane, incision route, implant texture, shape, volume, and operative pocket variables will be…
- Trial name
- NCT07810270
- Testing
- Aesthetic Breast Implantation, Standardized Implant Position Assessment
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
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
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 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
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
Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer
The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study…
- Conditions
- Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT04683679
- Testing
- Pembrolizumab, Olaparib, Radiation
- Where
- 7 sites in United States
- Volunteers
- 34 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Ambulatory Plastic Surgery, Esthetic Prosthetic Breast Expansion
Pectoral Nerve Block for Analgesia After Breast Augmentation
Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery.
- Trial name
- PECS B&BS (NCT02682186)
- Testing
- Ropivacaine after dilution with sodium chloride 0.9%
- Where
- 3 sites in France
- Volunteers
- 74 people
- Sponsor
- University Hospital, Montpellier
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