Clinical trials: Mastectomy With Reconstruction
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
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, DCIS
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct…
- Conditions
- Breast Cancer, DCIS, BRCA Mutation
- Trial name
- NCT06860217
- Testing
- Robotic Nipple-Sparing Mastectomy
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- European Institute of Oncology
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
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
Capsular Contracture Associated With Implant
Prevention of Capsular Contracture in Postmastectomy Patients Undergoing Implant-based Reconstructions
The study plans to evaluate capsular contracture at 1-year follow-up in postmastectomy patients receiving immediate implant-based reconstruction and Capsulase® supplementation in the postoperative period.
- Trial name
- NCT06785610
- Testing
- Capsulase®
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- European Institute of Oncology
Breast Cancer
Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR
Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery…
- Trial name
- DRAIN (NCT07237828)
- Testing
- Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
- Where
- China
- Volunteers
- 379 people
- Sponsor
- Du Zhenggui
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
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC).
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Trial name
- NCT06153836
- Testing
- Neurotization Procedure, Questionnaire Administration, Subcutaneous Mastectomy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Mayo Clinic
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
Breastcancer, Mastectomy
Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on Chronic Pain of a Mastectomy
A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a…
- Trial name
- PECS (NCT03023007)
- Testing
- Loco-regional anaesthesia
- Where
- France
- Volunteers
- 194 people
- Sponsor
- Centre Oscar Lambret
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 Reconstruction After Mastectomy
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
The purpose of this research study is to understand patient experiences and the feasibility of using a breast heat preconditioning device (Plexaa BLOOM43), designed to improve postoperative outcomes when used prior to mastectomy…
- Trial name
- NCT07516483
- Testing
- 1 Cycle Thermal Preconditioning, 3 Cycles Thermal Preconditioning, No Intervention
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University Health Sciences
Pain, Postoperative
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate…
- Trial name
- NCT03383198
- Testing
- Liposomal bupivacaine right injection, Liposomal bupivacaine left injection
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Prisma Health-Upstate
Postoperative Pain After Breast Reconstruction With Abdominal Flap
Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
The aim of this randomized, double-blind controlled trial is to determine the efficacy of transdermal fentanyl for the management of early postoperative pain in women undergoing mastectomy followed by immediate TRAM or DIEP flap…
- Trial name
- Fentanyl Patch (NCT01258296)
- Testing
- Fentanyl, Inactive patch
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Francisco
Breast Cancer
To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery.
- Trial name
- NCT06817954
- Testing
- endoscopic-assisted mastectomy and immediate breast reconstruction, mastectomy and immediate breast reconstruction
- Where
- China
- Volunteers
- 800 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer, Mastectomy
Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction.
- Conditions
- Breast Cancer, Mastectomy, Prepectoral Breast Reconstruction, ERAS Programmes
- Trial name
- AMADeuS (NCT07510698)
- Testing
- AMADeuS Perioperative Pathway, Usual Perioperative Care
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Rome Tor Vergata
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
Invasive Breast Cancer, Post-mastectomy
Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer
The purpose of this study is to see whether providing radiation on a shortened (compressed) schedule of 5 days in a row is a safe and effective approach to prevent cancer from coming back in people who have had a mastectomy.
- Trial name
- NCT04648904
- Testing
- Radiotherapy
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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