Clinical trials: Breast Reconstruction, open to volunteers
Breast Reconstruction, Thrombosis, Venous
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the…
- Conditions
- Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity
- Trial name
- MONITRANS2 (NCT05710705)
- Testing
- portable prototype of bioimpedance measurement
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
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
Breast Cancer, Breast Reconstruction
Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
This study investigates the safety and efficacy of hypofractionated radiotherapy (HFRT) versus conventional fractionated radiotherapy (CFRT) in breast cancer patients undergoing total mastectomy with prosthetic reconstruction.
- Conditions
- Breast Cancer, Breast Reconstruction, Radiation Oncology
- Trial name
- NCT07084519
- Testing
- hypofractionated radiotherapy, conventional fractionated radiotherapy
- Where
- China
- Volunteers
- 506 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Reconstruction, Mammary Reconstruction
A Clinical Study Evaluating the Safety and Performance of Eurosilicone Integrated Valve Tissue Expanders (IVTE)
Patients can undergo breast reconstruction surgery in two stages before implantation of the permanent prosthesis for several reasons.
- Trial name
- NCT07842406
- Testing
- Breast reconstruction surgery
- Volunteers
- 100 people
- Sponsor
- GCA (Eurosilicone)
Breast Cancer Female, Breast Reconstruction
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been…
- Trial name
- ADM (NCT06555614)
- Testing
- Acellular Dermal Matrix(ADM)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- DOF Inc.
Postoperative Seroma Rate, Drainage Tube Removal Time, and Capsular Contracture Rate, Seroma Following Procedure
Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants
Brief Summary This study hypothesizes that in immediate breast reconstruction following tumor resection, the application of inactivated Pseudomonas aeruginosa preparation (PAP) may reduce infection rates by decreasing…
- Trial name
- RCT of PAI + P (NCT07460297)
- Testing
- Pseudomonas aeruginosa, Povidone-Iodine
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Jianyi Li
Breast Cancer, Cancer of the Breast
ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT or Google Gemini generated patient education regarding possible reconstruction options) or…
- Trial name
- NCT06981208
- Testing
- ChatGPT or Google Gemini generated patient education, Usual patient education
- Where
- United States
- Volunteers
- 410 people
- Sponsor
- Washington University School of Medicine
Breast Reconstruction, Perfusion; Complications
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous Flap Viability in Breast Recon
The purpose of the study is to determine whether pharmacologic delay using minoxidil in patients undergoing bilateral risk reducing mastectomy with reconstruction could achieve improvement in flap perfusion and flap viability at…
- Conditions
- Breast Reconstruction, Perfusion; Complications, High Risk for Breast Cancer, Genetic Predisposition
- Trial name
- NCT07264790
- Testing
- Minoxidil, Hair mousse
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Duke University
Ductal Carcinoma in Situ, Breast Cancer
Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions
This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery.
- Trial name
- NCT06903468
- Testing
- Novel cavity marking technique
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Florida
Breast Cancer
Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction.
- Trial name
- HFIBR (NCT06830083)
- Testing
- Hypofractionated Radiation Therapy, Conventional fraction radiotherapy
- Where
- China
- Volunteers
- 840 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Reconstruction
Melodi Matrix™ in Breast Reconstruction
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
- Trial name
- NCT06027996
- Testing
- Absorbable Antibacterial Matrix
- Where
- 10 sites in United States
- Volunteers
- 702 people
- Sponsor
- Melodi Health, Inc.
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, 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, 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
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
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 Augmentation, Mammaplasty
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population.
- Trial name
- NCT06510205
- Testing
- Mentor Breast implants
- Where
- 4 sites in China
- Volunteers
- 6,111 people
- Sponsor
- Johnson & Johnson Medical (Shanghai) Ltd.
Wound Healing, Wound Healing Complication
Association Between Female Hormonal Profile and Wound Healing
The goal of this observational study is to assess the relationship between female hormonal status and postoperative wound healing in reduction mammaplasty. The main questions it aims to answer are: 1.
- Conditions
- Wound Healing, Wound Healing Complication, Estradiol
- Trial name
- FEMHEAL (NCT07724145)
- Where
- Switzerland
- Volunteers
- 84 people
- Sponsor
- University Hospital, Geneva
Breast Cancer
A Prospective Phase II Study for Adjuvant Hypofractionated Intensity-modulated Proton Radiotherapy for Post Operative Breast Cancer With Implantation Reconstruction
The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation…
- Trial name
- NCT05692674
- Testing
- adjuvant hypofractionated intensity-modulated proton radiotherapy
- Where
- China
- Volunteers
- 67 people
- Sponsor
- Shanghai Proton and Heavy Ion Center
Breast Cancer
Effects of Expectations and Body Image in Breast Reconstruction
A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life.
- Trial name
- NCT04714463
- Testing
- Implant-based breast reconstruction, Autologous breast reconstruction, Combined methods
- Where
- Sweden
- Volunteers
- 500 people
- Sponsor
- Vastra Gotaland Region