Clinical trials: Breast Reconstruction Following Mastectomy, open to volunteers
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 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 Reconstruction
Prosthetic Breast Reconstruction After Mastectomy
Breast cancer represents a disabling diagnosis for women, and the related destructive surgical intervention of mastectomy inevitably affects their social, relational and working life.
- Trial name
- BrREC2020 (NCT06774352)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 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
Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients
The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following…
- Conditions
- Breast Cancer, Breast Reconstruction, Breast Reconstruction After Mastectomy, Breast Cancer Radiation
- Trial name
- AFT-R (NCT07641985)
- Testing
- Autologous fat transfer, Deep inferior epigastric perforator flap
- Where
- Netherlands
- Volunteers
- 280 people
- Sponsor
- Maastricht University Medical Center
Breast Cancer, Radiotherapy; Complications
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy…
- Trial name
- NCT05253170
- Testing
- Hypofractionation, Conventional Fractionation
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Seoul National University Bundang Hospital
Breast Reconstruction, Radiation Dermatitis
Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients
The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).
- Conditions
- Breast Reconstruction, Radiation Dermatitis, Radiation Fibrosis, Fat Grafting
- Trial name
- NCT04992650
- Testing
- Fat grafting
- Where
- United States
- Volunteers
- 15 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 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
Breast Cancer, Breast Neoplasms, Breast Reconstruction
Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction
Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Reconstruction, DIEP Flap Breast Reconstruction, Robotic Surgery
- Trial name
- REBORN (NCT07230535)
- Testing
- Robotic Assisted Nipple Sparing Mastectomy, Standarding Open Nipple Sparing Mastectomy
- Where
- Ireland
- Volunteers
- 250 people
- Sponsor
- Beaumont Hospital
Breast Cancer, Breast Reconstruction
The Outcomes of Fat Grafting Combined With Latissimus Dorsi Muscle Flap for Delayed Breast Reconstruction After Mastectomy
The outcomes of fat grafting combined with latissimus dorsi muscle flap for delayed breast reconstruction after mastectomy
- Trial name
- NCT07331753
- Testing
- Fat grafting combined with latissimus dorsi muscle flap
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Sohag University
Breast Reconstruction, Deep Inferior Epigastric Perforator
Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free…
- Conditions
- Breast Reconstruction, Deep Inferior Epigastric Perforator, Breast Reconstruction After Mastectomy
- Trial name
- NCT07851415
- Testing
- Restrata®
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Seroma, Breast Cancer
Seroma of the Mammary Gland
The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists).
- Conditions
- Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications
- Trial name
- SerMa (NCT05899387)
- Testing
- Swap collection, Seroma punction, Blood sampling
- Where
- Germany
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- University Hospital Augsburg
Sensation Disorder
A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM).
- Trial name
- NIPSENSE (NCT07062458)
- Testing
- Nipple Sensation Assessment
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Candiolo Cancer Institute - IRCCS
Breast Cancer
The Comparison Between DEDTI BR and T/E BR
This is a national multicenter, prospective, cohort study. The study aims to compare surgical safety (e.g., surgical complication rates), surgery-related indicators (e.g., operation time, number of operations, surgery-related…
- Trial name
- DETE-BR (NCT07593846)
- Testing
- Delayed endoscopic direct-to-implant breast reconstruction, Two-stage expander-to-implant breast reconstruction
- Where
- China
- Volunteers
- 412 people
- Sponsor
- West China Hospital
Breast Reconstruction After Mastectomy
A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy
In China, low breast-conserving surgery rates and historically minimal immediate reconstruction following mastectomy have resulted in a significant population of women living without a breast, often leading to long-term…
- Trial name
- DEDIA (NCT07602868)
- Volunteers
- 263 people
- Sponsor
- West China Hospital
Breast Cancer Surgery, Reconstruction Breast Surgery
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or…
- Conditions
- Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization, DIEP Flap Breast Reconstruction
- Trial name
- S-DIEP (NCT06930378)
- Testing
- Nerve Suture
- Where
- Switzerland
- Volunteers
- 63 people
- Sponsor
- Patricia Esther Engels
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
Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery…
- Trial name
- NCT06512259
- Testing
- AlloMend® Acellular Dermal Matrix allograft
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- AlloSource