Clinical trials: Mastectomy and Breast Reconstruction
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
Breast Cancer
Evaluation of SOMAVAC 100 Sustained Vacuum System
The purpose of this research study is to compare the effectiveness of the Somavac 100 Sustained Vacuum System versus manual section bulbs after immediate breast reconstruction.
- Trial name
- NCT04845256
- Testing
- SOMAVAC 100 Sustained Vacuum System
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Tennessee
Deep Inferior Epigastric Artery Perforator Flap Breast Reconstruction
The Effect of Volatile Anesthesia and Total Intravenous Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Mastectomy and Breast Reconstruction Using Deep Inferior Epigastric Artery Perforator Free Flap
The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 in patients undergoing mastectomy and…
- Trial name
- NCT05136508
- Testing
- Propofol, Sevoflurane
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Yonsei University
Breast Cancer
Breast Capsular Contracture Following Post-Mastectomy Reconstruction in Women Treated With the Leukotriene Inhibitor Zafirlukast: A Phase II Trial
A 2 arm, 90 patient (45 per cohort) trial in patients with breast cancer who will be undergoing mastectomy with immediate tissue-expander reconstruction to determine whether treatment with zafirlukast (20mg PO BID) can reduce or…
- Trial name
- NCT02950480
- Testing
- zafirlukast, Standard of Care (no intervention)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of California, San Francisco
Breast Cancer, Mastectomy
Patient Activated Controlled Expansion (PACE) Trial
The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction.
- Conditions
- Breast Cancer, Mastectomy, Breast Reconstruction
- Trial name
- PACE (NCT01009008)
- Testing
- Patient Activated Controlled Expansion Device
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- AirXpanders, Inc.
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
Breast Cancer
Patient Preferences for Breast Reconstruction After Mastectomy
Deciding whether or not to have breast reconstruction after mastectomy is highly challenging for many patients. This study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life…
- Trial name
- NCT01488357
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Nipple-sparing Mastectomy, Immediate Prosthesis Reconstruction
Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction
Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation.
- Conditions
- Nipple-sparing Mastectomy, Immediate Prosthesis Reconstruction, Endoscopic Surgery, Robotic Surgery
- Trial name
- EnRoNSM (NCT06748677)
- Where
- China
- Volunteers
- 484 people
- Sponsor
- Peking University People's Hospital
Breast Cancer Female
Assessment of Breast Cancer Patients Satisfaction and Health Related Quality of Life Outcomes
The purpose of the study is to learn more about the quality of life and satisfaction with breast cancer surgical treatment and education from patient reported outcome data.
- Trial name
- NCT03333122
- Where
- United States
- Volunteers
- 575 people
- Sponsor
- Henry Ford Health System
Malignant Breast Neoplasm
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
This clinical trial evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer.
- Trial name
- NCT05408260
- Testing
- Ultrasonography, Automated Breast Ultrasound
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Thomas Jefferson University
Breast Cancer
Local and Regional Radiotherapy for Nipple Sparing Mastectomy With Implant
The prospective observational study of radiation therapy is conducted on the nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node) with a high…
- Trial name
- NCT05213962
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- National Cancer Center, Korea
Breast Cancer
Targeted Nerve Surgery for the Prevention of Post-Mastectomy Pain Syndrome: A Randomized Trial
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain condition often caused by neuroma formation and nerve injury following breast cancer surgery.
- Trial name
- NCT07146009
- Testing
- Nerve Surgery, Standard of Care (Investigator Choice)
- Volunteers
- 60 people
- Sponsor
- Advanced Reconstructive Surgery Alliance
Postoperative Complications, Recurrence
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction.
- Conditions
- Postoperative Complications, Recurrence, Breast Neoplasms, Breast Cancer
- Trial name
- SORI (NCT04108117)
- Testing
- Robotic nipple sparing mastectomy
- Where
- South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Severance Hospital
Breast Neoplasms
Randomized Phase II Trial: Chest Wall RT Omission After Prosthetic Reconstruction
The goal of this randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy (RT) after prosthetic reconstruction in early-stage breast cancer patients.
- Trial name
- NCT06464913
- Testing
- With or without chest wall RT
- Where
- China
- Volunteers
- 152 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Cancer, Ductal Carcinoma
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
- Trial name
- NCT01208974
- Testing
- Nipple-Sparing Mastectomy, Breast Reconstruction, Axillary Surgery
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Miami
Breast Cancer, Breast Cancer Female
Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction
The purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for…
- Trial name
- NCT04016376
- Testing
- PVB Protocol, PECS-1, Serratus
- Where
- United States
- Volunteers
- 1,507 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Radiation Dermatitis, Skin Microbiome
The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
The breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find…
- Conditions
- Radiation Dermatitis, Skin Microbiome, Breast Cancer, Reconstructive Surgery
- Trial name
- NCT05032768
- Testing
- post-operative radiotherapy
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Fudan University
Breast Cancer Female
Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.
- Trial name
- NCT03523078
- Testing
- Breast reconstructive surgery
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Yonsei University
Mastectomy; Lymphedema, Breast Cancer
Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of…
- Conditions
- Mastectomy; Lymphedema, Breast Cancer, Quality of Life
- Trial name
- NCT04356235
- Testing
- A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction, B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling, C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
- Where
- Hungary
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- National Institute of Oncology, Hungary
Breast Cancer
Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis.
- Trial name
- MARCI (NCT02673268)
- Testing
- Mastectomy, Da Vinci Robot Xi
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris