Clinical trials: Mastectomy and Breast Reconstruction
Breast Cancer
Laser Speckle Imaging During Breast Reconstruction
Around 3500 women a year have surgery to reconstruct a breast/s after cancer. Breast reconstruction can have a positive impact on their lives, but unfortunately 3 or 4 in 10 women have problems with healing after their operation.
- Trial name
- SIMBAR (NCT06523452)
- Testing
- Laser Speckle Imaging
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Royal Devon and Exeter NHS Foundation Trust
Other Reconstructive Surgery
Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Pedicled transverse rectus abdominus myocutaneous (TRAM) flaps are the most common post-mastectomy breast reconstructive surgeries that utilize the patient's tissue.
- Trial name
- NCT01262599
- Testing
- Ivivi Torino II PEMF Device
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Columbia University
Breast Cancer, Malignant Neoplasm of Breast
Breast Reconstruction Following Breast Cancer in Very High Risk Patients
The purpose of this study is to: 1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of…
- Trial name
- NCT03261323
- Testing
- Immediate Breast Reconstruction, Delayed Breast Reconstruction, Breast-Q questionnaire
- Where
- United States
- Sponsor
- Case Comprehensive Cancer Center
Breast Cancer, Postoperative Pain
Comparison of Pre-op and Post-op Pectoralis Nerve Block
The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after mastectomy.
- Conditions
- Breast Cancer, Postoperative Pain, Anesthesia, Nerve Block
- Trial name
- NCT03653988
- Testing
- PEC I/II blocks by anesthesiologist - pre-operative, PEC I/II blocks by surgeon - intra-operative
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Melinda Seering
Breast Cancer, Mastectomy; Lymphedema
Same-Day Discharge After Nipple-sparing Mastectomy or Skin-sparing Mastectomy With Breast Reconstruction
This novel study will assess the feasibility and outcomes of same-day discharge following mastectomy with implant-based pre-pectoral reconstruction.
- Conditions
- Breast Cancer, Mastectomy; Lymphedema, Same Day Surgery, Nipple-sparing Mastectomy
- Trial name
- NCT04596683
- Testing
- Same-day NSM or SSM
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Georgetown University
Breast Cancer
Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer
Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction.
- Trial name
- NCT04640454
- Testing
- nipple sparing mastectomy
- Where
- Egypt
- Volunteers
- 35 people
- Sponsor
- Alexandria University
Breast Cancer
Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with…
- Trial name
- NCT07372339
- Testing
- Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction, Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
- Volunteers
- 170 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Mammaplasty, Mastectomy
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro…
- Conditions
- Mammaplasty, Mastectomy, Lumpectomy
- Trial name
- NCT00466765
- Testing
- Brava Autologous Fat Transfer System
- Where
- 2 sites in United States
- Volunteers
- 589 people, healthy volunteers welcome
- Sponsor
- Brava
Implant Based Breast Reconstruction
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire.
- Trial name
- TIGR-Matrix (NCT06511167)
- Testing
- TIGR® Matrix
- Where
- 5 sites in Germany
- Volunteers
- 135 people
- Sponsor
- AWOgyn
Surgery Date, Age
Quality of Life of Patients Who Have Undergone Bilateral Mastectomy
The investigators therefore aim to determine whether the type of mastectomy (preventive in a high-risk patient or therapeutic in a patient with a history of cancer), as well as the timing (immediate or delayed) and type of breast…
- Conditions
- Surgery Date, Age, BMI, Height
- Trial name
- RM BREAST Q (NCT07699913)
- Volunteers
- 115 people
- Sponsor
- University Hospital, Grenoble
Pain, Postoperative, Non-Opioid Pain Management
Virtual Reality After Breast Reconstruction Surgery
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction.
- Conditions
- Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
- Trial name
- VR4BR (NCT03801616)
- Testing
- Virtual Reality
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Breast Cancer, Breast Cancer Female
Microbiome and Association With Implant Infections
The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples.
- Conditions
- Breast Cancer, Breast Cancer Female, Genetic Predisposition to Disease
- Trial name
- NCT05020574
- Testing
- Cephalexin
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of California, San Francisco
Mastectomy
RCT Implant Based Breast Reconstruction
The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are…
- Trial name
- NCT04558138
- Testing
- Discharge timing
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- University of Colorado, Denver
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, Quality of Life
The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction
The investigators conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of prepectoral breast reconstruction in women with breast cancer and high risk.
- Conditions
- Breast Cancer, Quality of Life, Surgery--Complications
- Trial name
- PreQ-20 (NCT04642508)
- Testing
- Prepectoral reconstruction
- Where
- Spain
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- University Hospital A Coruña
Nipple-sparing Mastectomy, Prophylactic Mastectomy
Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer.
- Conditions
- Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer, BRCA1 Mutation
- Trial name
- NCT05448963
- Testing
- da Vinci SPⓇ Single-port System
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Chang Gung Memorial Hospital
Mastectomy, Breast Reconstruction
Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240…
- Trial name
- RMR (NCT04457167)
- Testing
- Robot-assisted, Not robot-assisted surgery
- Where
- France
- Volunteers
- 480 people
- Sponsor
- Institut Paoli-Calmettes
Breast Cancer, Breast Reconstruction
Nipple Sparing Mastectomy - Cosmetic Outcomes
The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.
- Conditions
- Breast Cancer, Breast Reconstruction, Cosmesis
- Trial name
- NCT01002014
- Testing
- Nipple Sparing Mastectomy
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Breast Neoplasm
Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction
Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block.
- Trial name
- NCT02913573
- Testing
- Ultrasound, 0.25% bupivacaine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Huntington Memorial Hospital
Breast Implant; Complications, Breast Implant Infection
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction
The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the…
- Conditions
- Breast Implant; Complications, Breast Implant Infection, Implant Capsular Contracture, Breast Seroma
- Trial name
- RTADM (NCT06139588)
- Testing
- acellular dermal matrix implant for breast reconstruction
- Where
- Italy
- Volunteers
- 146 people
- Sponsor
- European Institute of Oncology