Clinical trials: Breast Reconstruction
Breast Cancer
Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)
Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and…
- Trial name
- REMASCO (NCT02553967)
- Testing
- Functional MRI
- Where
- France
- Volunteers
- 49 people
- Sponsor
- Centre Oscar Lambret
Tissue Expansion, Breast Reconstruction
Patient Performed Tissue Expansion for Two-stage Alloplastic Breast Reconstruction
This study is designed to evaluate the feasibility and safety of patient performed tissue expansions in two-stage alloplastic breast reconstruction with tissue expanders.
- Trial name
- NCT04781907
- Testing
- Tissue Expansion
- Where
- United States
- Sponsor
- University of Wisconsin, Madison
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
Pain, Postoperative, Obesity
Bilateral Thoracic Paravertebral Blocks in Obese and Non-obese Patients Undergoing Reduction Mammaplasty
Aim: Although regional anesthesia (RA) techniques are advantageous in the anesthetic management of obese patients (body mass index (BMI)≥30); their performances can still be associated with technical difficulties and greater…
- Conditions
- Pain, Postoperative, Obesity, Thoracic Paravertebral Blocks, Ultrasound
- Trial name
- NCT04596787
- Testing
- Bilateral Thoracic paravertebral block
- Volunteers
- 82 people
- Sponsor
- Istanbul University
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
Breast Cancer, DCIS
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct…
- Conditions
- Breast Cancer, DCIS, BRCA Mutation
- Trial name
- NCT06860217
- Testing
- Robotic Nipple-Sparing Mastectomy
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- European Institute of Oncology
Post-Mastectomy Breast Deformity (Disorder)
Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
- Trial name
- NCT05484934
- Testing
- Regenerative post mastectomy surgery
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- BioAesthetics
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
ciNPT in Autologous Abdominal Tissue Breast Reconstruction
In women who undergo mastectomy for the treatment of breast cancer, autologous reconstruction using the deep inferior epigastric perforator (DIEP) flap is a common surgical procedure that aims to restore both the appearance and…
- Trial name
- NCT04985552
- Testing
- DIEP Breast Reconstruction, ciNPT, Conventional Tape Dressings
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- McMaster University
Breast Reduction, Reduction Mammoplasty
Risk of Hematoma After Ketorolac Use in Reduction Mammoplasty.
The investigators hope to answer the question, "does ketorolac increase the risk of hematoma after reduction mammoplasty?" using a case-control study.
- Conditions
- Breast Reduction, Reduction Mammoplasty, Hematoma, Hemorrhage
- Trial name
- NCT03280043
- Testing
- Hematoma
- Where
- 2 sites in Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- McMaster University
Implant Complication, Implant Infection
Local Antibiotics for Breast Implants
The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after…
- Conditions
- Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture
- Trial name
- BREAST-AB (NCT04731025)
- Testing
- Gentamicin, Cefazolin and Vancomycin
- Where
- 8 sites in Denmark
- Volunteers
- 1,003 people, healthy volunteers welcome
- Sponsor
- Mikkel Herly
Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction
Comparison of Mastectomy Expander Trial
Expanders are used outside their intended use, due to two following facts: It is possible that expander implantation exceed the "approved" duration of 6 months (maximal 10 months).
- Conditions
- Mastectomy and Breast Reconstruction, Tissue Expander Based Breast Reconstruction, Adjuvant Radiotherapy, Long Term Outcome
- Trial name
- COMMET (NCT07434648)
- Testing
- intervention (unilateral/bilateral), scheduled for (NSME/SSME), indication (breast cancer diagnosis (malignancy) with neoadjuvant chemotherapy or DCIS diagnosis without neoadjuvant chemotherapy
- Volunteers
- 80 people
- Sponsor
- Medical University Innsbruck
Breast Cancer
Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction
The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC has been associated with significantly higher ipsilateral breast tumor recurrences.The accuracy of breast tumor excision in BCS can…
- Trial name
- BCSMANC (NCT01917578)
- Testing
- Ultrasound, CNB, BCS, Modified Radical Mastectomy
- Where
- China
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Shandong Cancer Hospital and Institute
Mastectomy and Breast Reconstruction, Sexual Wellness
Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys. This data can support preoperative patient counselling and the prevention and care of adverse effects of…
- Trial name
- NCT07234461
- Testing
- Survey using a questionnaire.
- Where
- 19 sites in Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- European Institute of Oncology
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
Post-Mastectomy Chronic Pain Syndrome (Disorder)
Cryoablation for Post Mastectomy Pain Syndrome
This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment…
- Trial name
- NCT03293940
- Testing
- Cryoablation, Therapeutic Peripheral Nerve Block (tPNB) Injection
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- Emory University
Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue.
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer, Stage IA Breast Cancer
- Trial name
- NCT01729832
- Testing
- breast reconstruction, intraoperative imaging
- Sponsor
- Ohio State University Comprehensive Cancer Center
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
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
Breast Cancer
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy.
- Trial name
- AllodermRCT (NCT00956384)
- Testing
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Where
- 4 sites in Canada
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto