Clinical trials: Breast Implants
Breast Augmentation, Breast Reconstruction
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01959880
- Testing
- The Contour Profile Gel (CPG) breast implants
- Where
- United States
- Volunteers
- 1,891 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Postpartum Contraception, Family Planning
Labor and Delivery Implant Insertion: A Randomized Controlled Trial
A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis.
- Trial name
- LADII (NCT02866643)
- Testing
- Etonogestrel-Immediate, Etonogestrel-Delayed
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Stanford University
Mastectomy; Lymphedema, Breast Cancer
Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of…
- Conditions
- Mastectomy; Lymphedema, Breast Cancer, Quality of Life
- Trial name
- NCT04356235
- Testing
- A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction, B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling, C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
- Where
- Hungary
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- National Institute of Oncology, Hungary
Breast Cancer
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy.
- Trial name
- AllodermRCT (NCT00956384)
- Testing
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Where
- 4 sites in Canada
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
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
Micromastia, Breast Ptosis
Autologous Fat Grafting to the Breast
Structural fat grafting is a form of tissue transfer where the autologous fat is harvested and subsequently transferred to a different region of the body at the same setting.
- Conditions
- Micromastia, Breast Ptosis, Implant Failure, Breast Reconstruction
- Trial name
- NCT00775788
- Testing
- Autologous Fat Grafting to Breasts
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Louisiana State University Health Sciences Center in New Orleans
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01853605
- Testing
- Anatomically shaped silicone gel-filled breast implants
- Where
- United States
- Volunteers
- 3,811 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Implant; Complications, Infection or Inflammation
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal…
- Trial name
- NCT05744414
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AlloSource
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 Reconstruction
Direct to Implant Breast Reconstruction Based Pre- or Retropectoral
The purpose of this study is to examine different outcomes of breast reconstruction in women who are treated for breast cancer with skin sparing mastectomy and subsequently a primary implant based reconstruction by one of two…
- Trial name
- NCT03143335
- Testing
- Retropectoral immediate breast reconstruction, Prepectoral immediate breast reconstruction
- Where
- 3 sites in Denmark, Norway
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
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
Capsular Contracture, Implant
Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast
- Trial name
- NCT03171974
- Testing
- Dexamethasone, US
- Where
- Israel
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Rabin Medical Center
Breast Cancer
Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation
- Trial name
- NCT01711710
- Testing
- Cohesive Gel Breast Implant
- Where
- 2 sites in South Korea
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Breast Augmentation
European New Texture Implant Clinical Experience With Shaped Breast Implants
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
- Trial name
- NCT01639755
- Testing
- new texture shaped breast implants
- Where
- 2 sites in Sweden
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01785069
- Testing
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
- Where
- 29 sites in United States
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Reconstruction, Patient Education
Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
This pilot study uses a randomized controlled trial design to introduce an educational session for breast reconstruction patients. Participants will be randomly assigned to the (1) control group or the (2) experimental group.
- Trial name
- RESTORE (NCT03743753)
- Testing
- Experimental
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- McMaster University
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
Mammogram Scheduled
Comparison of Stationary Breast Tomosynthesis and 2-D Digital Mammography in Patients With Breast Augmentation
Purpose:The aim of this research is to compare the 3D s-DBT (stationary digital breast tomosynthesis) and conventional 2-D digital mammography devices with regards to patient comfort and radiologist preference in women with…
- Trial name
- NCT02008032
- Testing
- Stationary Breast Tomosynthesis
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Breast Augmentation, Breast Reconstruction
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled X-Style and L-Style Breast Implants…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01870869
- Testing
- Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
- Where
- 58 sites in United States
- Volunteers
- 1,951 people, healthy volunteers welcome
- Sponsor
- Allergan
Capsular Contracture Associated With Implant, Foreign-Body Reaction
Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis
The goal of this single-center, randomised double-blinded trial is to compare the early stage fibrosis progression around conventional textured expander and the SmoothSilk® expander with reduced surface roughness in women…
- Conditions
- Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries, Tissue Expander Disorder
- Trial name
- NCT05648929
- Testing
- Patient Satisfaction Questionnaire, Pregnancy test, Blood draw
- Where
- Austria
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck