Clinical trials: Implant Breast Reconstruction
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 Carcinoma, Breast Reconstruction
Prepectoral and Subpectoral Implant-based Breast Reconstruction
Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase…
- Trial name
- NCT04688697
- Testing
- prepectoral implant-based reconstruction, subpectoral implant-based reconstruction
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Fudan University
Breast Cancer, Operable Breast Cancer
EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes
Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction.
- Trial name
- EXPRESSO (NCT07593651)
- Volunteers
- 276 people
- Sponsor
- IRCCS San Raffaele
Breast Implant; Complications
Breast Reconstruction
Complications following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity.
- Trial name
- NCT06332937
- Testing
- postmastectomy breast reconstruction
- Where
- South Korea
- Volunteers
- 5,000 people
- Sponsor
- Seoul National University Hospital
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
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
Mastectomy, Breast Cancer
Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction
Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome.
- Trial name
- NCT03959709
- Testing
- immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement., Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- Ottawa Hospital Research Institute
Mastectomy, Infections
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
This study will look at the rate of infections developed by subjects comparing the use of disposable draping systems versus reusable draping systems in the operating room.
- Conditions
- Mastectomy, Infections, Breast Reconstruction
- Trial name
- NCT01176786
- Testing
- Culture Swabs, Rodac Plate Cultures
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Wake Forest University Health Sciences
Breast Reconstruction, Breast Cancer
Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction.
- Conditions
- Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery
- Trial name
- Reborn-i (NCT07236359)
- Testing
- Intervention, Standard open nipple sparing mastectomy with immediate implant-based reconstruction
- Volunteers
- 108 people
- Sponsor
- Beaumont Hospital
Breast Cancer
Biological Matrices Versus Synthetic Meshes
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months.
- Trial name
- BIOSYM (NCT05449691)
- Testing
- One-stage immediate breast reconstruction
- Where
- 5 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Breast Augmentation, Breast Reconstruction
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
The aim of this observational, Post-market, Retro-prospective, open, non-randomized, non-comparative, multicentric, European study is to evaluate the safety and performance of the Monobloc® - Silicone SoftOne® breast implants at…
- Trial name
- SOFTONE (NCT07904091)
- Testing
- Breast augmentation, Breast reconstruction
- Where
- 5 sites in France
- Volunteers
- 630 people
- Sponsor
- Laboratoires ARION
Breast Cancer, Hereditary Breast and Ovarian Cancer Syndrome
Tissue Expansion in Breast Reconstruction Without Drains
The primary objective of this small feasibility pilot study is to demonstrate that implant-based breast reconstruction (after treatment for cancer) can successfully be performed without prolonged drain placement, using a tissue…
- Conditions
- Breast Cancer, Hereditary Breast and Ovarian Cancer Syndrome, Breast Implant; Complications
- Trial name
- NCT03784859
- Testing
- Insertion of Tissue Expander with Fluid Reservoir
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Cedars-Sinai Medical Center
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)
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 Neoplasms
Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction
Introduction: physical therapy is essential in preventing motor and functional complications after breast cancer surgery. However, there is no prospective randomized study of different physiotherapy approaches in patients…
- Trial name
- NCT02480842
- Testing
- Alloplastic free ROM, Alloplastic limited ROM, Oncoplastic free ROM
- Where
- Brazil
- Volunteers
- 120 people
- Sponsor
- Federal University of São Paulo
Mammary Cancer, Erector Spinae Plane Block
Effect of ESPB on Postoperative Pain in Patients With Breast Cancer Implant Reconstruction
Nowadays, the incidence of breast cancer is the first number of malignant tumors, and the primary treatment method is surgery.With the development of medical technology and concept, radical mastectomy combined breast…
- Conditions
- Mammary Cancer, Erector Spinae Plane Block, Postoperative Pain
- Trial name
- NCT06143020
- Testing
- Erector spinae plane block
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
Breast Reconstruction Following Mastectomy
Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing…
- Trial name
- NCT02775409
- Testing
- Subcutaneous placement, Submuscular placement
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Mayo Clinic
Perfusion; Complications
The Effect of Nitroglycerin Ointment, Fluorescent Angiography, and Incisional Negative Pressure Wound Therapy on Mastectomy Skin Flap Perfusion-Related Problems
This is a randomized study using a variety of techniques to compare and examine blood flow to the remaining skin after mastectomy. All treatments being used are considered standard of care and are not experimental.
- Trial name
- NCT03716050
- Testing
- Nitroglycerin, Negative Pressure Wound Therapy/ Wound VAC, Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer
The Comparison Between DEDTI BR and T/E BR
This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related…
- Trial name
- DETE-BR (NCT07593846)
- Testing
- Delayed endoscopic direct-to-implant breast reconstruction, Two-stage expander-to-implant breast reconstruction
- Where
- China
- Volunteers
- 412 people
- Sponsor
- West China Hospital
Breast Cancer
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
- Trial name
- NCT02061527
- Testing
- Reconstruction with ADM., Skin or nipple sparing mastectomy, Reconstruction with implant
- Where
- 5 sites in Sweden, United Kingdom
- Volunteers
- 135 people
- Sponsor
- Karolinska University Hospital