Clinical trials: Breast Implant, open to volunteers
Surgical Site Infection, Surgical Complication
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections…
- Conditions
- Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication
- Trial name
- NCT06649890
- Testing
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
Breast Reconstruction
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
- Trial name
- NCT06575192
- Testing
- ARTIA Reconstructive Tissue Matrix
- Where
- 23 sites in United States
- Volunteers
- 264 people
- Sponsor
- AbbVie
Breast Cancer
Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction.
- Trial name
- HFIBR (NCT06830083)
- Testing
- Hypofractionated Radiation Therapy, Conventional fraction radiotherapy
- Where
- China
- Volunteers
- 840 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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 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 Reconstruction Following Mastectomy
Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with…
- Trial name
- NCT07819357
- Testing
- Allogeneic Nerve Grafting
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Endeavor Health
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 Cancer, Capsular Contracture Associated With Breast Implant
Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction
This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.
- Trial name
- PRETORIA (NCT04342546)
- Testing
- NovaGray RILA Breast® test
- Where
- 9 sites in France
- Volunteers
- 250 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
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
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
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 Carcinoma
Postoperative Outcomes and Patient Satisfaction With Mayo Clinic Florida Care Hotel After Mastectomy and Tissue Expander Placement
This study evaluates the postoperative outcomes of patients who are admitted to the Mayo Clinic Florida Care Hotel after mastectomy and tissue expander placement.
- Trial name
- NCT06783179
- Testing
- Non-Interventional Study
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Mayo Clinic
Breast Cancer
A Comparative Study of Delayed Endoscopic DTI and Latissimus Dorsi ±Impalnt Reconstruction Post-Mastectomy
Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively.
- Trial name
- DELTI (NCT07757074)
- Testing
- Surgery options
- Where
- China
- Volunteers
- 268 people
- Sponsor
- Du Zhenggui
Breast Cancer
International Prospective REgistry on Pre-pectorAl Breast REconstruction
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer.
- Trial name
- I-PREPARE (NCT05817175)
- Testing
- pre-pectoral breast reconstruction
- Where
- 11 sites in Argentina, Egypt and 7 more
- Volunteers
- 1,236 people
- Sponsor
- European Breast Cancer Research Association of Surgical Trialists
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- Trial name
- NCT06823414
- Testing
- Video assisted mastectomy
- Where
- Spain
- Volunteers
- 126 people
- Sponsor
- Alejandra García-Novoa
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
Mammaplasty, Breast Cancer
Motiva Flora® Aesthetic Breast Recon® Clinical Study
The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement…
- Conditions
- Mammaplasty, Breast Cancer, Poland Syndrome
- Trial name
- NCT06146231
- Testing
- Motiva Flora® Tissue Expander
- Where
- 4 sites in Belgium, Colombia and 2 more
- Volunteers
- 66 people
- Sponsor
- Establishment Labs