Clinical trials: Mastectomy and Breast Reconstruction
Breast Cancer
Mastectomy Reconstruction Outcomes Consortium (MROC) Study
The MROC Study seeks to evaluate and compare from the patient's point of view the leading options for breast reconstruction after mastectomy.
- Trial name
- MROC (NCT01723423)
- Where
- 11 sites in United States, Canada
- Volunteers
- 4,436 people
- Sponsor
- University of Michigan
Mastectomy, Breast Reconstruction
CiNPWT Using in Mastectomy Wound Care After DIEP Flaps for Breast Reconstruction
Background: Closed-incision negative pressure wound therapy (ciNPWT) is effective in reducing postoperative complications, yet its use in free flap breast reconstruction mastectomy wound remains controversial due to concerns that…
- Conditions
- Mastectomy, Breast Reconstruction, Closed-Incision Negative Pressure Therapy
- Trial name
- NCT07546968
- Testing
- Closed-Incision Negative Pressure Wound Therapy (CiNPWT)
- Where
- Taiwan
- Volunteers
- 253 people
- Sponsor
- Chiayi Christian Hospital
Breast Cancer
BREAST Choice Decision Tool R21 - AIM2
Breast reconstruction is a critical component of breast cancer treatment because it restores quality of life and body image after mastectomy.
- Trial name
- BREASTChoice (NCT06817226)
- Testing
- Pre-survey, BREASTChoice tool., Post-survey
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Pre-Pectoral Breast Reconstruction Following Mastectomy
Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
- Trial name
- NCT06853964
- Testing
- AlloMend® Acellular Dermal Matrix allograft
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- AlloSource
Genetic Predisposition, Breast Cancer
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume.
- Trial name
- MRIMOP (NCT03838549)
- Testing
- Prophylactic mastectomy with immediate breast reconstruction
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
Post-mastectomy Breast Reconstruction
Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
- Trial name
- NCT04477538
- Testing
- Post-mastectomy breast reconstruction physical well-being survey
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-sparing Matectomy With Reconstruction in Early-Stage Breast Cancer Patients
This study is testing a new, less invasive way to perform breast cancer surgery using a single-port robotic system (a robot-assisted surgical tool made in China, called the Shurui SR-ENS-600).
- Trial name
- NCT07781163
- Testing
- single-port robot-assisted surgery
- Volunteers
- 30 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Breast Neoplasms
Application of Intra-operative Prophylactic Antibiotics/Antiseptics in Chinese Breast Reconstruction Patients
The study aims to investigate different approaches of local application of antibiotics/antiseptics intraoperatively in Chinese patients undergoing post-mastectomy implant based breast reconstruction, and aims to single out an…
- Trial name
- NCT03742908
- Testing
- Cefazolin/clindamycin
- Where
- China
- Volunteers
- 291 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Cancer
Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy
At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of…
- Trial name
- HIST-RIC (NCT02679040)
- Testing
- Immediate mammary reconstruction, Chemotherapy, Radiation therapy
- Where
- 10 sites in France
- Volunteers
- 101 people
- Sponsor
- Institut Paoli-Calmettes
Breast Neoplasms, Germline BRCA1 Gene Mutation
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and…
- Conditions
- Breast Neoplasms, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Benign Breast Disease
- Trial name
- MARRES (NCT04585074)
- Testing
- Robotic or endoscopic nipple sparing mastectomy, Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
- Where
- 18 sites in South Korea
- Volunteers
- 2,000 people
- Sponsor
- Severance Hospital
Breast Cancer
Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT
This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction.
- Trial name
- NCT01664091
- Testing
- post-mastectomy radiation therapy (PMRT), tissue expander (TE), acellular dermal matrix (ADM)
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Mastectomy
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.
- Trial name
- NCT01781299
- Testing
- AlloDerm RTU, SurgiMend PRS
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Pittsburgh
Breast Conserving Surgery, Mastectomy With Reconstruction
A Study of the BREAST-Q REACT Tool for People Having Breast Surgery
The researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life…
- Trial name
- NCT06550401
- Testing
- BREAST-Q Physical Well-Being, QuickDASH
- Where
- 6 sites in United States
- Volunteers
- 69 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Reconstruction After Mastectomy, Neurotization
Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components
This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women…
- Conditions
- Breast Reconstruction After Mastectomy, Neurotization, Mastectomy and Breast Reconstruction, Peripheral Nerve Regeneration
- Trial name
- NCT07308275
- Testing
- Autologous Breast Reconstruction With Direct Neurotization, Autologous Breast Reconstruction without Neurotization
- Where
- Indonesia
- Volunteers
- 28 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Breast Cancer, Breast Reconstruction
The Use of Laser-Assisted Indocyanine Green Dye Angiography to Predict Mastectomy Skin Flap Viability
In the investigators previous study of 51 breast reconstructions (32 patients), we compared three different assessments of vascular perfusion of tissue; clinical judgment, fluorescein dye angiography (FDA) and laser-assisted…
- Conditions
- Breast Cancer, Breast Reconstruction, Mastectomy
- Trial name
- ICG (NCT01554267)
- Testing
- Laser-Assisted ICG Dye Angiography (SPY System)
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Stony Brook University
Breast Cancer, LCIS
Tumor: Breast Ratio Study
This is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.
- Conditions
- Breast Cancer, LCIS, DCIS
- Trial name
- T:B (NCT02216136)
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- Washington University School of Medicine
Breast Cancer, Breast Reconstruction
EndoBreast Study - Assessment of Feasibility, Functional Outcomes, and Sensitivity of the Areola-Nipple Complex in Endoscopic Mastectomy
Study Design Prospective, single-center, observational, non-interventional study conducted in routine clinical practice. No investigational treatments or modifications to standard diagnostic, therapeutic, or follow-up procedures…
- Trial name
- EndoBreast (NCT07718425)
- Testing
- endoscopic mastectomy
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Massimiliano Bortolini
Breast Pain, Post-Op Complication
Serratus and Parasternal Infrapectoral Block for Breast Surgery.
Effective pain control is important following breast surgery as it improves quality of recovery, decreases the risk of chronic pain development and reduction of overall health care cost.
- Trial name
- NCT03708302
- Testing
- Unilateral serratus plane block, Unilateral parasternal infrapectoral block
- Where
- Canada
- Volunteers
- 120 people
- Sponsor
- Western University, Canada
Breast Carcinoma
A 3D-Printed External Breast Prosthesis for the Improvement of Patient-reported Outcomes Among Breast Cancer Patients That Underwent a Mastectomy Without Reconstruction
This clinical trial evaluates whether a three-dimensional (3D)-printed external breast prosthesis improves patient-reported outcomes (PRO) among breast cancer patients that underwent surgical removal of the breast (mastectomy)…
- Trial name
- NCT07047872
- Testing
- Computer-Aided Diagnosis, Prosthetics Intervention, Questionnaire Administration
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Mayo Clinic
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