Clinical trials: Mammary Reconstruction
Breast-Conserving Surgery
Regenerative Collagen Scaffold for Breast Volume Restoration After Breast Cancer Excision
This clinical trial evaluates the safety and efficacy of High Purity Type I Collagen scaffold for breast volume restoration following breast-conserving surgery (BCS).
- Trial name
- NCT07219316
- Testing
- High Purity Type I Collagen Scaffold (Regenerative Matrix)
- Where
- 2 sites in India
- Volunteers
- 40 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Breast Cancer
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast…
- Trial name
- NCT01823107
- Testing
- Meso BioMatrix Device
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Kensey Nash Corporation
Breast Cancer
Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions
The purpose of this study is to determine if a radiation treatment called "Multi-beam Intensity Modulated Radiation Therapy"(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy.
- Trial name
- NCT02086578
- Testing
- Breast MRI, Breast-Q© questionnaire, Multi-Beam IMRT
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach
Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking.
- Trial name
- NCT03346161
- Testing
- Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction", Decision tool, Usual Care Group - Outcome Measures
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Washington University School of Medicine
Pain, Postoperative, Non-Opioid Pain Management
Virtual Reality After Breast Reconstruction Surgery
This is a pilot study of virtual reality (VR) non-opioid management for women undergoing mastectomy and implant-based reconstruction.
- Conditions
- Pain, Postoperative, Non-Opioid Pain Management, Virtual Reality
- Trial name
- VR4BR (NCT03801616)
- Testing
- Virtual Reality
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Pain, Postoperative, Mammaplasty
Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander
Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken.
- Trial name
- NCT04278846
- Testing
- Depofoam bupivacaine, Bupivacaine hydrochloride (HCl)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- The Cleveland Clinic
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study
Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00690339
- Testing
- Style 410 Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 941 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Nonmalignant Breast Conditions, Breast Cancer
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and…
- Trial name
- NCT01286168
- Testing
- Sodium hypochlorite (Dakin's Solution), Chlorhexidine gluconate disk, Control
- Where
- 2 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Macromastia
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures.
- Trial name
- NCT00558246
- Testing
- Dermabond Protape (Prineo), Suture
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 79 people
- Sponsor
- Ethicon, Inc.
Breast Cancer, Breast Reconstruction
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
- Conditions
- Breast Cancer, Breast Reconstruction, Nipple Reconstruction
- Trial name
- NRC (NCT01216319)
- Testing
- Nipple reconstruction
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cook Group Incorporated
Breast Cancer Female
PEMF and PEC Blocks in Mastectomy Reconstruction Patients
This is a prospective randomized controlled double-blind interventional study comparing the effect of pulsed-electromagnetic field device (PEMF), pectoral interfascial block (PIB), and placebo on postoperative pain control.
- Trial name
- NCT03360214
- Testing
- Bupivacaine Hydrochloride, Pulsed Electromagnetic Field (PEMF) Device, Ropivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Breast Augmentation, Breast Reconstruction
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
At a national level of 15%, the reoperation rate following augmentation mammaplasty is too high. We are conducting a survey to examine the pre-operative methods by which plastic surgeons determine implant volume, size, shape and…
- Trial name
- NCT00684749
- Where
- United States
- Volunteers
- 142 people
- Sponsor
- University of Minnesota
Breast Cancer
Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction
Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders.
- Trial name
- NCT02725801
- Testing
- Allergen one-port tissue expander placement, AlloX2 two-port tissue expander placement
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Lesley Wong
Breast Cancer, Breast Cancer Female
Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction
The purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for…
- Trial name
- NCT04016376
- Testing
- PVB Protocol, PECS-1, Serratus
- Where
- United States
- Volunteers
- 1,507 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast - Female
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
The primary objective is to determine if pre-operative transversus abdominis plane (TAP) nerve blocks by continued infusion of local anesthetic post-operatively affects post-operative narcotic usage, as compared to a placebo TAP…
- Trial name
- NCT02601027
- Testing
- Transversus Abdominis Plane (TAP) block, Nimbus Infusion Pump IV Administration, Bupivacaine infusion
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Stanford University
Breast Cancer
Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic…
- Trial name
- Split-Dose (NCT01653964)
- Testing
- Molecular breast imaging
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Breast Cancer
Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT
This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction.
- Trial name
- NCT01664091
- Testing
- post-mastectomy radiation therapy (PMRT), tissue expander (TE), acellular dermal matrix (ADM)
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Dana-Farber Cancer Institute
Ductal Breast Carcinoma, Invasive Breast Carcinoma
Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.
- Conditions
- Ductal Breast Carcinoma, Invasive Breast Carcinoma, Lobular Breast Carcinoma, Medullary Breast Carcinoma
- Trial name
- NCT03414970
- Testing
- Radiation Therapy, Questionnaire Administration, Quality-of-Life Assessment
- Where
- 859 sites in United States, Canada
- Volunteers
- 898 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Venous Thromboembolism
Apixaban vs Enoxaparin Following Microsurgical Breast Reconstruction-An RCT
Subcutaneous enoxaparin is currently the gold standard for VTE chemoprophylaxis. However, the efficacy of chemoprophylaxis with subcutaneous enoxaparin is affected by patient-level factors, thus, resulting in VTE events despite…
- Trial name
- NCT04504318
- Testing
- Apixaban 2.5 MG Oral Tablet, Enoxaparin 40Mg/0.4mL Prefilled Syringe
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Stanford University
Breast Reconstruction, Breast Cancer
Implementing BREASTChoice Into Practice
Breast reconstruction after mastectomy is a highly personal decision. Although it can restore quality of life for many, there are numerous risks associated with the procedure.
- Trial name
- NCT04491591
- Testing
- Breast Reconstruction Education and Support Tool (BREASTChoice), Attention Control Website, Clinician Survey
- Where
- 2 sites in United States
- Volunteers
- 396 people
- Sponsor
- Washington University School of Medicine