Clinical trials: Breast Augmentation, open to volunteers
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
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 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 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
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, 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 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
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
Breast Augmentation
Improved Breast Enlargement Using the Subject's Own Fat Tissue
The goal of this clinical study is to learn if the Medical Device Under Investigation (simply "the device") is safe to use in human adults undergoing breast augmentation surgery.
- Trial name
- SWIFT (NCT07869641)
- Testing
- An injectable, biodegradable hydrogel, in reconstitution medium, Reconstitution medium
- Where
- 2 sites in Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- 4Tissue
Augmentation, Fibroadenoma
Regional Anesthesia Techniques in Breast Surgery
This clinical trial aims to evaluate the efficacy of liposomal bupivacaine and ropivacaine, when administered via paravertebral block, the rhomboid intercostal and subserratus plane (RISS) block, PECS II block, intercostal nerve…
- Conditions
- Augmentation, Fibroadenoma, Mastectomy
- Trial name
- NCT06779656
- Testing
- General Anesthesia (GA), Paravertebral Block (PVB), Rhomboid Intercostal and Subserratus Plane Block (RISS)
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Xiaguang Duan
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 Cancer, Breast Reconstruction
Implant-based Breast Reconstruction in Post-bariatric Women - a Registry-based National Study
The goal of this national registry-based study is to investigate the prevalence of reconstructive breast surgery and risk factors for surgical complications in women who have had weight loss surgery previously.
- Conditions
- Breast Cancer, Breast Reconstruction, Bariatric Surgery, Breast Implant
- Trial name
- NCT07059104
- Testing
- Breast augmentation, Breast reconstruction after mastectomy
- Where
- Sweden
- Volunteers
- 20,000 people
- Sponsor
- Vastra Gotaland Region
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
Breast Ptosis
Hybrid Autologous Breast Augmentation in Mastopexy With Internal BRA Fixation; Using Local Breast Tissues and Fat Grafting
The breast is a very important organ for women's self-esteem and is regarded as a symbol of femininity. Deviations from normal size, shape, and symmetry are interpreted as unattractive and a sign of aging.
- Trial name
- NCT07197190
- Testing
- Autologous augmentation mastopexy with subpectoral lipofilling and upper and medial pole fat grafting.
- Where
- Egypt
- Volunteers
- 28 people
- Sponsor
- Assiut University
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 Prosthesis; Pain, Postoperative Pain
Effect of Bilateral Rhomboid Intercostal Block on Postoperative Pain After Breast Implant Surgery
This prospective, randomized, single-center, study aims to evaluate the postoperative analgesic effectiveness of bilateral Rhomboid Intercostal Block (RIB) in patients undergoing elective bilateral breast prosthesis surgery.
- Conditions
- Breast Prosthesis; Pain, Postoperative Pain, Breast Augmentation
- Trial name
- RIB-BREAST (NCT07448246)
- Testing
- Rhomboid intercostal plane block
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Aydin Adnan Menderes University
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