Clinical trials: Mastectomy and Breast Reconstruction
Breast Reconstruction After Mastectomy, Neurotization
Longitudinal Evaluation of Direct Neurotization Technique in Breast Reconstruction With Fully Autologous Components
This clinical trial aims to evaluate whether direct neurotization using fully autologous components during autologous breast reconstruction improves postoperative breast sensation and sensory-related quality of life in women…
- Conditions
- Breast Reconstruction After Mastectomy, Neurotization, Mastectomy and Breast Reconstruction, Peripheral Nerve Regeneration
- Trial name
- NCT07308275
- Testing
- Autologous Breast Reconstruction With Direct Neurotization, Autologous Breast Reconstruction without Neurotization
- Where
- Indonesia
- Volunteers
- 28 people
- Sponsor
- Fakultas Kedokteran Universitas Indonesia
Breast Cancer
TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction
The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator…
- Trial name
- NCT05301595
- Testing
- TAP block, QL Block
- Where
- Canada
- Sponsor
- Ottawa Hospital Research Institute
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 Neoplasms, Germline BRCA1 Gene Mutation
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and…
- Conditions
- Breast Neoplasms, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Benign Breast Disease
- Trial name
- MARRES (NCT04585074)
- Testing
- Robotic or endoscopic nipple sparing mastectomy, Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
- Where
- 18 sites in South Korea
- Volunteers
- 2,000 people
- Sponsor
- Severance Hospital
Pain, Postoperative
Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate…
- Trial name
- NCT03383198
- Testing
- Liposomal bupivacaine right injection, Liposomal bupivacaine left injection
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Prisma Health-Upstate
Postoperative Pain After Breast Reconstruction With Abdominal Flap
Postoperative Pain Control With Fentanyl Patch in Patients Undergoing Mastectomy and TRAM or DIEP Flap Reconstruction
The aim of this randomized, double-blind controlled trial is to determine the efficacy of transdermal fentanyl for the management of early postoperative pain in women undergoing mastectomy followed by immediate TRAM or DIEP flap…
- Trial name
- Fentanyl Patch (NCT01258296)
- Testing
- Fentanyl, Inactive patch
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of California, San Francisco
Breast Reconstruction, Breast Cancer
Immediate Breast Reconstruction's Increasing
Mastectomy in breast cancer is still a way of treatment. Nowadays, the goal is to improve reconstruction's technicals. Immediate Breast Reconstruction (IBR) is one of them, largely used in United States but less in France.
- Trial name
- IBRI (NCT04888351)
- Testing
- Comparison of complications between mastectomies with IBR and mastectomies without IBR, To analyze variations of number of patients eligibles to IBR
- Where
- France
- Volunteers
- 215 people
- Sponsor
- Hospices Civils de Lyon
Breast Cancer Female
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.
- Trial name
- DREAM-RMI (NCT05527769)
- Testing
- mastectomy + immediate breast reconstruction
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Institut Cancerologie de l'Ouest
Breast Cancer
To Evaluate the Effectiveness and Safety of Mastectomy Combined With Immediate Breast Reconstruction in Breast Cancer (NJMU-Reconstruction Cohort)
The new technology of endoscopic-assisted system, as an emerging technology, has shown certain application prospects in breast surgery.
- Trial name
- NCT06817954
- Testing
- endoscopic-assisted mastectomy and immediate breast reconstruction, mastectomy and immediate breast reconstruction
- Where
- China
- Volunteers
- 800 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Implant; Complications, Breast Implant Protrusion
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound…
- Conditions
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer, Radiotherapy Side Effect
- Trial name
- BLITE-01 (NCT03737500)
- Testing
- B-Lite® light weight breast implant, Standard silicone-based breast implant
- Where
- Italy
- Volunteers
- 49 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Breast Reconstruction, Breast Cancer
Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy
A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022.
- Trial name
- NCT05943873
- Where
- Taiwan
- Volunteers
- 63 people
- Sponsor
- Chang Gung Memorial Hospital
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
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, 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, Breast Cancer
Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction
Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome.
- Trial name
- NCT03959709
- Testing
- immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement., Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- Ottawa Hospital Research Institute
Breast Surgery, Macromastia
Comparison of ESP and SPSIP Blocks in Breast Surgery
This study aims to compare the efficacy of the ESP and SPSIP blocks in managing postoperative pain following breast surgery. Breast surgery, particularly after oncological and reconstructive procedures, often leads to significant…
- Conditions
- Breast Surgery, Macromastia, Mammaplasty, Modified Radical Mastectomy
- Trial name
- NCT06611644
- Testing
- Erector Spinae Plane Block, SPSIPB blcok, Control
- Where
- Turkey (Türkiye)
- Volunteers
- 75 people
- Sponsor
- Çanakkale Onsekiz Mart University
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
Malignant Breast Neoplasm
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
This clinical trial evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer.
- Trial name
- NCT05408260
- Testing
- Ultrasonography, Automated Breast Ultrasound
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Thomas Jefferson University
Breast Cancer
Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-sparing Matectomy With Reconstruction in Early-Stage Breast Cancer Patients
This study is testing a new, less invasive way to perform breast cancer surgery using a single-port robotic system (a robot-assisted surgical tool made in China, called the Shurui SR-ENS-600).
- Trial name
- NCT07781163
- Testing
- single-port robot-assisted surgery
- Volunteers
- 30 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine