Clinical trials: Breast Reconstruction, active
Breast Reconstruction, Free Flap Reconstruction
ESP Blocks in Breast Free Flaps
This study is a prospective randomized controlled trial to assess the efficacy of erector spinae plane (ESP) blocks in patients undergoing autologous free flap breast reconstruction.
- Trial name
- NCT07891039
- Testing
- Bupivacaine with Epinephrine and Dexamethasone
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Carilion Clinic
Breast Reconstruction, Breast Cancer Patients
Autologous Nerve Graft Breast Reconstruction Neurotization
The goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. The patient-reported outcome was assessed by questionnaire.
- Conditions
- Breast Reconstruction, Breast Cancer Patients, Nipple-sparing Mastectomy
- Trial name
- NCT06629012
- Testing
- Breast reconstruction with neurotization, Breast reconstruction without neurotization
- Where
- Taiwan
- Volunteers
- 250 people
- Sponsor
- Chang Gung Memorial Hospital
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
Mastectomy, Implant Based Breast Reconstruction
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain.
- Trial name
- NCT05975359
- Testing
- Interi Manifold Drain System, Jackson Pratt Drain System
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Stanford 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
Breast Reconstruction, Revision Breast Reconstruction
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
- Trial name
- Athena (NCT02724371)
- Testing
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
- Where
- 30 sites in United States
- Volunteers
- 400 people
- Sponsor
- Mentor Worldwide, LLC
Primary Breast Augmentation, Primary Breast Reconstruction
Memory Gel and Shape Combined Cohort
The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or…
- Conditions
- Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction
- Trial name
- Glow (NCT02919592)
- Testing
- MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery
- Where
- 78 sites in United States
- Volunteers
- 3,603 people
- Sponsor
- Mentor Worldwide, LLC
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, 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)
Post-operative Pain, DIEP Flap Breast Reconstruction
Suzetrigine Post DIEP
This research study is being conducted to see whether adding suzetrigine (Journavx), an FDA-approved non-opioid pain medication, to the standard Enhanced Recovery After Surgery (ERAS) pain management protocol can improve pain…
- Conditions
- Post-operative Pain, DIEP Flap Breast Reconstruction, DIEP Flap, Opioid
- Trial name
- NCT07839715
- Testing
- Suzetrigine Group
- Volunteers
- 198 people
- Sponsor
- Vanderbilt University Medical Center
Breast Augmentation, Breast Reconstruction
Sientra Post-Approval Study
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01639053
- Where
- United States
- Volunteers
- 5,498 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
Breast Reconstruction
Effectiveness and Safety of OviTex® PRS in Breast Reconstruction
The purpose of this study is to evaluate the safety and effectiveness of OviTex PRS in subjects undergoing implant-based breast reconstruction.
- Trial name
- RESTORE (NCT07135596)
- Testing
- OviTex PRS
- Where
- 3 sites in United States
- Volunteers
- 235 people
- Sponsor
- Tela Bio Inc
Breast Cancer, Implant Breast Reconstruction
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
This is a prospective, randomized controlled, non-inferiority clinical trial designed to compare the outcomes of hypofractionated radiotherapy versus conventionally fractionated radiotherapy following mastectomy and implant-based…
- Trial name
- NCT07835139
- Testing
- ConvRT, HypoRT
- Where
- China
- Volunteers
- 534 people
- Sponsor
- Fudan University
Breast Cancer, Physiotherapy
Evaluation of the Impact of Pre-habilitation Using Physiotherapy and Mechanical Stimulation on Shoulder Pain and Mobility in Patients Undergoing Breast Reconstruction Using a Latissimus Dorsi Flap
Each year in France, nearly 59,000 new cases of breast cancer are diagnosed, and approximately 22,000 mastectomies are performed. Among these patients, 30% choose to undergo breast reconstruction.
- Conditions
- Breast Cancer, Physiotherapy, Breast Reconstruction, Latissimus Dorsi Flap
- Trial name
- PREHAB KINELGD (NCT07418060)
- Testing
- Prehabilitation with physiotherapy including mechanostimulation, No Prehabilitation with physiotherapy including mechanostimulation
- Where
- 2 sites in France
- Volunteers
- 96 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
Breast Conserving Surgery, Mastectomy With Reconstruction
A Study of the BREAST-Q REACT Tool for People Having Breast Surgery
The researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the BREAST-Q Real-time Engagement and Communication Tool (REACT) on people's quality of life…
- Trial name
- NCT06550401
- Testing
- BREAST-Q Physical Well-Being, QuickDASH
- Where
- 6 sites in United States
- Volunteers
- 69 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, Breast Reconstruction
Immediate Autologous Tissue Breast Reconstruction and Radiotherapy Strategy After Breast Cancer Surgery
This is a prospective, open-label, controlled clinical trial aiming to investigate the optimal sequencing strategy between immediate autologous tissue breast reconstruction and radiotherapy in breast cancer patients.
- Conditions
- Breast Cancer, Breast Reconstruction, Radiotherapy
- Trial name
- NCT07798466
- Testing
- Immediate DIEP flap breast reconstruction, Hypofractionated radiotherapy
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Fudan University
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 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