Clinical trials: Breast Implants
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, Breast Implant Protrusion
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound…
- Conditions
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer, Radiotherapy Side Effect
- Trial name
- BLITE-01 (NCT03737500)
- Testing
- B-Lite® light weight breast implant, Standard silicone-based breast implant
- Where
- Italy
- Volunteers
- 49 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Mastectomy; Lymphedema, Breast Cancer
Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy
The purpose of this multicenter retrospective cohort study is to determine the effect of radiotherapy on capsular contraction and implant loss rates in patients undergoing prepectoral immediate implant-based breast reconstruction…
- Trial name
- PRExRT (NCT06747065)
- Testing
- Radiotherapy
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Basel, Switzerland
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
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
Mastectomy, Breast Reconstruction
Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction
Use of a HADM and implant in post-mastectomy breast reconstruction.
- Trial name
- NCT02263261
- Testing
- Flex HD Pliable Perforated HADM
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Musculoskeletal Transplant Foundation
Breast Augmentation, Breast Reconstruction
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT00905645
- Testing
- Silimed Gel-Filled Mammary Implant
- Where
- United States
- Volunteers
- 1,788 people
- Sponsor
- Tiger Biosciences, 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
Ventral Hernia, Post-mastectomy Breast Reconstruction
Analysis and Characterization of Biologic Implants
The purpose of this study is to investigate what happens to biologic mesh in the body over time on a molecular level. To date, it is not known what agents, enzymes, or proteins are interacting at the implantation site that…
- Trial name
- NCT01060046
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of…
- Trial name
- NCT04391296
- Testing
- Arm I (Prepectoral), Arm II (Subpectoral)
- Volunteers
- 114 people
- Sponsor
- Gangnam Severance Hospital
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
Breast Cancer, Implant Breast Reconstruction
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based…
- Trial name
- NCT07835139
- Testing
- ConvRT, HypoRT
- Where
- China
- Volunteers
- 534 people
- Sponsor
- Fudan University
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 Cancer Female
Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes.
- Trial name
- RM2prepec (NCT04343820)
- Testing
- Breast reconstruction
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Institut Cancerologie de l'Ouest
Advanced Breast Cancer, Early Breast Cancer
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.
- Trial name
- NCT07310420
- Testing
- ZOLADEX
- Where
- 26 sites in United States
- Volunteers
- 176 people
- Sponsor
- TerSera Therapeutics LLC
Breast Cancer
Study to Compare the Safety of Immediate One-stage IBBR With Expander-Implant Two-stage IBBR Augmented With TiLoop® Bra(COSTA)
This study is the first prospective randomized study assessing the safety and patient-reported outcomes of immediate one-stage IBBR compared with those of two-stage IBBR with TiLoop® Bra.
- Trial name
- IBBR (NCT03589924)
- Testing
- Immediate IBBR+TiLoop®Bra, Immediate-delayed IBBR+TiLoop®Bra
- Where
- 11 sites in China
- Volunteers
- 440 people
- Sponsor
- Jiong Wu
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
Patient and Surgical Related Risk Factors for Complications
TiLoop® Bra for Breast Reconstruction
A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM).
- Trial name
- NCT01544023
- Volunteers
- 207 people
- Sponsor
- University of Rostock
Breast Implant; Complications, Breast Expansion Prosthesis
Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
The use of breast implants, both in cosmetic and restorative surgery, is common. It is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline.
- Trial name
- INFLAMA (NCT06414785)
- Testing
- analysis of samples of periprosthetic capsules taken during breast implant change procedure
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Breast Cancer
Autologous vs. Implant-based Breast Reconstruction
Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective.
- Trial name
- GoBreast II (NCT06195865)
- Testing
- DIEP-flap, Implant
- Where
- 2 sites in Sweden
- Volunteers
- 250 people
- Sponsor
- Vastra Gotaland Region