Clinical trials: Breast Reconstruction
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 Reconstruction
Nipple Reinnervation in Two-stage Alloplastic Breast Reconstruction.
A prospective study was conducted including patients undergoing nipple-sparing mastectomy with neurotization during expander-to-implant exchange between 2021 and 2025.
- Trial name
- NCT07767838
- Testing
- Nipple neurotization
- Where
- Mexico
- Volunteers
- 18 people
- Sponsor
- Hospital Angeles del Pedregal
Breast Neoplasms, Breast Reconstruction
DIEP-MDS for Risk Stratification of Flap Vascular Compromise and Failure in Breast Reconstruction
This multicenter retrospective observational study will develop and validate a CTA-based quantitative risk score-the DIEP Morphological Deviation Score (DIEP-MDS)-to estimate the risk of flap-related vascular compromise and flap…
- Conditions
- Breast Neoplasms, Breast Reconstruction, Postoperative Complications
- Trial name
- DIEP-MDS (NCT07761390)
- Where
- 20 sites in China
- Volunteers
- 1,500 people
- Sponsor
- Zhuliling
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 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, Acquired Absence of Breast
Long-term Evaluation of Quality of Life and Aesthetic Outcomes After Autologous Breast Reconstruction Using the Profunda Artery Perforator (PAP) Flap
Breast reconstruction using autologous tissue is an important option for women undergoing mastectomy for breast cancer. The profunda artery perforator (PAP) flap is a reliable alternative when abdominal tissue is unavailable or…
- Conditions
- Breast Cancer, Acquired Absence of Breast, Autologous Breast Reconstruction
- Trial name
- QUALIPAP (NCT07728565)
- Where
- France
- Volunteers
- 264 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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, Breast Cancer
Access My Breast Cancer Care App
The Access my Breast Cancer Care application was developed by a multidisciplinary team with the intention of providing breast cancer patients with a centralized area to navigate their journey.
- Trial name
- NCT07696637
- Testing
- Access My Breast Cancer Care App, Standard Pathway
- Where
- 2 sites in Canada
- Volunteers
- 148 people
- Sponsor
- University of British Columbia
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
Breast Augmentation, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)
Breast Cancer, Breast Reconstruction
NIR Device for Assessment of Skin Flap Perfusion in Breast Surgery: A Pilot Interventional Study
The goal of this single-center, nonrandomized, interventional non-profit pilot study is to evaluate the feasibility and clinical utility of a non-invasive near-infrared spectroscopy (NIRS) imaging device for assessing skin-flap…
- Conditions
- Breast Cancer, Breast Reconstruction, Mastectomy
- Trial name
- ADisIRast (NCT07680296)
- Testing
- Snapshot NIR V3.0
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- National Research Council, Institute of Clinical Physiology, Italy
DIEP Flap, Breast Reconstruction
ORASIS in Breast Reconstruction
The purpose of this study is to assess the use of ORASIS during microsurgical anastomosis formation in Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction and its potential effects on surgical precision, surgeon…
- Conditions
- DIEP Flap, Breast Reconstruction, Breast Cancer
- Trial name
- NCT07670754
- Testing
- Use of ORASIS Device
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Duke University
Tissue Expansion, Implant Based Breast Reconstruction
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order…
- Trial name
- NCT05975372
- Testing
- Blossom tissue expander, Standard tissue expansion
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Stanford University
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, 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
Mastectomy, Mammaplasty
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.
- Conditions
- Mastectomy, Mammaplasty, Breast Reconstruction
- Trial name
- NCT04891510
- Testing
- REVOLVE Advanced Adipose System, LipoGrafter, Viality
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Weill Medical College of Cornell University
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
Mammaplasty, Breast Reconstruction
Custom Breast Implants With 3D Imaging
The aim of this study is to use MRI and Vectra metadata from patients in order to develop the "customizable" aspect of the MyBREAST One implant through computer modeling of this implant based on the collected metadata.
- Trial name
- NCT07628517
- Volunteers
- 25 people
- Sponsor
- HELMo Link asbl
Breast Augmentation and Breast Reconstruction, Mammaplasty
Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction
This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction.
- Conditions
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation
- Trial name
- NCT07623564
- Testing
- Mia Harmonization, Mia Scarless Lift, Mia Reconstruction
- Where
- Costa Rica
- Volunteers
- 60 people
- Sponsor
- Establishment Labs
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs