Clinical trials: Breast Implant
Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)
Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry
Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant.
- Trial name
- NCT04220970
- Testing
- BIA-ALCL
- Where
- 31 sites in Belgium, France
- Volunteers
- 150 people
- Sponsor
- The Lymphoma Academic Research Organisation
Contraception
BLIS - Breastfeeding Levonorgestrel IUD Study
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to…
- Trial name
- BLIS (NCT01990703)
- Testing
- Levonorgestrel IUD
- Where
- 2 sites in United States
- Volunteers
- 285 people
- Sponsor
- University of Utah
Breast Cancer
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate…
- Trial name
- NEARSENSE (NCT07902661)
- Testing
- Nerve anastomosis
- Volunteers
- 110 people
- Sponsor
- Gangnam Severance Hospital
Breast Augmentation, Breast Reconstruction
A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants…
- Trial name
- NCT04261608
- Where
- 6 sites in China
- Volunteers
- 225 people
- Sponsor
- Allergan
Breast Neoplasms
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?
The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy.
- Trial name
- NCT02637635
- Testing
- Autologous fat transplantation, Expander prosthesis
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- Karolinska Institutet
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding…
- Trial name
- NCT01853436
- Testing
- Strattice™ Reconstructive Tissue Matrix
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- LifeCell
Breast Reconstruction
Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction
The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction.
- Trial name
- Neo-Matrix (NCT07480421)
- Testing
- Acellular matrix
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Silimed Industria de Implantes Ltda
Breast Implantation
Retrospective Study of Reoperation After Primary Augmentation With NATRELLE® INSPIRA® Breast Implants
This study will evaluate the incidence of reoperations associated with the use of smooth and textured NATRELLE® INSPIRA® TruForm® 1 and TruForm® 2 devices in patients who have undergone primary breast augmentation.
- Trial name
- RANBI-I (NCT02438332)
- Testing
- Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants, Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants, Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants
- Where
- 17 sites in Canada
- Volunteers
- 330 people
- Sponsor
- Allergan
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
Breast Implant Infection
Infection After Implant-based Breast Reconstruction
Infections following postmastectomy breast reconstruction can compromise surgical outcomes and lead to significant morbidity. The aim of this study was to determine factors associated with infection following two-stage…
- Trial name
- NCT06187649
- Testing
- breast reconstruction
- Volunteers
- 5,000 people
- Sponsor
- Seoul National University Hospital
Breast Cancer
Cost-Effectiveness of Abdominal-based Autogenous Tissue vs Tissue Expander-Implant Reconstruction - A Feasibility Study
It is estimated that about 25% and 40% of health care expenditures in Canada and USA respectively are wasted because of inefficiencies and not practicing evidence-based medicine.
- Trial name
- NCT02438449
- Testing
- Breast Reconstruction Surgery
- Where
- Canada
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- McMaster University
Breast Cancer
Testosterone Implants and the Incidence of Breast Cancer
This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.
- Trial name
- TIBCaP (NCT03768258)
- Testing
- Testosterone Implant
- Volunteers
- 1,268 people
- Sponsor
- Millennium Wellness LLC
Breast Implants
Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue
The use of autograft of adipose tissue for aesthetic breast augmentation is increasing year after year. According to the latest meta-analysis of 2016, autograft of adipose tissue in augmentation mastoplasty seems to be a…
- Trial name
- AMEP (NCT06147661)
- Where
- France
- Volunteers
- 119 people
- Sponsor
- University Hospital, Strasbourg, France
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Diseases
REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy.
- Trial name
- NCT05533099
- Testing
- Observational study
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Tensive SRL
Breast Cancer
Pilot Study for 3-Dimensional Surface Imaging in Implant-based Breast Reconstruction
Measuring appearance of implant-based breast reconstruction after mastectomy for breast cancer - an online approach to research.
- Trial name
- 3D-SI (NCT03203252)
- Testing
- Reconstruction BREAST-Q, 3-dimensional Surface Image, Treatment Questionnaire
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Carcinoma
Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction
Hypofractionated radiotherapy could provide more convenient treatment and had similar toxicities.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare,Some studies have shown…
- Trial name
- NCT05045287
- Testing
- hypofractionated radiotherapy
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Chinese Academy of Medical Sciences
Breast Neoplasms
Clinical Outcomes and Complications in Two-stage Breast Reconstruction Using Microtextured and Nanotextured Expanders
This retrospective observational study evaluates clinical outcomes and complication rates in women who underwent two-staged implant-based breast reconstruction using tissue expanders and implants following mastectomy for breast…
- Trial name
- RA-IBBR-NvsM (NCT07442838)
- Where
- Slovakia
- Volunteers
- 88 people
- Sponsor
- Comenius University
Paravertebral Catheter Insertion, Mastectomy
Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks
Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.
- Conditions
- Paravertebral Catheter Insertion, Mastectomy, Breast Cancer
- Trial name
- NCT01231204
- Testing
- Ropivicaine 0.4% Continuous Infusion
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Diego
Breast Reconstruction, Breast Cancer
Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction
Scope of tumor resection was simulated according to the MR imaging data. After meticulous design, the investigators created the personalized porous biodegradable scaffold and printed by 3D printer, using porous PCL biomaterials.
- Trial name
- NCT03348293
- Testing
- 3D printing
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xijing Hospital