Clinical trials: Mastectomy and Breast Reconstruction, open to volunteers
Surgical Site Infection, Surgical Complication
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections…
- Conditions
- Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication
- Trial name
- NCT06649890
- Testing
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
Breast Reconstruction
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
- Trial name
- NCT06575192
- Testing
- ARTIA Reconstructive Tissue Matrix
- Where
- 23 sites in United States
- Volunteers
- 264 people
- Sponsor
- AbbVie
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 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
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 Cancers, Mastectomy and Breast Reconstruction
Prediction of ICG for Skin Necrosis in Mastectomy With Immediate Reconstruction
Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women.
- Conditions
- Breast Cancers, Mastectomy and Breast Reconstruction, Skin Necrosis
- Trial name
- NCT06956443
- Volunteers
- 50 people
- Sponsor
- University Medical Center Groningen
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
Sensation Disorders, Sensation, Phantom
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and…
- Conditions
- Sensation Disorders, Sensation, Phantom, Pain, Postoperative, Pain, Chronic
- Trial name
- NCT06094257
- Testing
- Sensory testing
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Skin Necrosis, Breast Reconstruction
B4P Trial - BLOOM43 for Preconditioning
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer.
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Trial name
- NCT07340632
- Testing
- BLOOM43
- Volunteers
- 60 people
- Sponsor
- Plexaa Ltd
Breast Neoplasms, Breast Carcinoma
Preoperative Radiation Therapy and Immediate Breast Reconstruction
The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of…
- Conditions
- Breast Neoplasms, Breast Carcinoma, Breast Adenocarcinoma, Cancer
- Trial name
- PRADAIIBE (NCT06739655)
- Testing
- Preoperative radiotherapy, Postoperative radiotherapy, Immediate breast reconstruction
- Where
- 6 sites in Belgium
- Volunteers
- 180 people
- Sponsor
- Cancer Research Antwerp
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 Cancer
International Prospective REgistry on Pre-pectorAl Breast REconstruction
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer.
- Trial name
- I-PREPARE (NCT05817175)
- Testing
- pre-pectoral breast reconstruction
- Where
- 11 sites in Argentina, Egypt and 7 more
- Volunteers
- 1,236 people
- Sponsor
- European Breast Cancer Research Association of Surgical Trialists
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- Trial name
- NCT06823414
- Testing
- Video assisted mastectomy
- Where
- Spain
- Volunteers
- 126 people
- Sponsor
- Alejandra García-Novoa
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
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate…
- Trial name
- NEARSENSE (NCT07902661)
- Testing
- Nerve anastomosis
- Volunteers
- 110 people
- Sponsor
- Gangnam Severance Hospital