Clinical trials: Mammoplasty Patient
Breast Cancer, Quality of Life
The PreQ-20 TRIAL, a Prospective Cohort Study of Patients Undergoing Prepectoral Breast Reconstruction
The investigators conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of prepectoral breast reconstruction in women with breast cancer and high risk.
- Conditions
- Breast Cancer, Quality of Life, Surgery--Complications
- Trial name
- PreQ-20 (NCT04642508)
- Testing
- Prepectoral reconstruction
- Where
- Spain
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- University Hospital A Coruña
Breast Cancer, Breast Reconstruction
Study of AeroForm Tissue Expander for Breast Reconstruction
This study is intended to support previous positive results of the AeroForm™ Patient Controlled Tissue Expander System for breast reconstruction
- Trial name
- ASPIRE (NCT01903174)
- Testing
- AeroForm Breast Tissue Expander
- Where
- Australia
- Volunteers
- 21 people
- Sponsor
- AirXpanders, Inc.
Breast Reconstruction After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Breast Cancer
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Nipple -Sparing Mastectomy (NSM), with immediate breast reconstruction (IBR) can be offered to patients requiring mastectomy when the lesion is more than 2cm from the nipple.
- Trial name
- NEOMAMENDO (NCT06569706)
- Testing
- Nipple-Sparing Mastectomy, with immediate breast reconstruction
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
Breast Cancer
Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial
The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of…
- Trial name
- NCT04391296
- Testing
- Arm I (Prepectoral), Arm II (Subpectoral)
- Volunteers
- 114 people
- Sponsor
- Gangnam Severance Hospital
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 Implant; Complications, Breast Implant Infection
Comparative Analysis of Two Animal-derived ADMs in Irradiated Implant-based Reconstruction
The goal of this retrospective observational trial is to compare two different devices, used in implant-based breast reconstruction, called acellular dermal matrices, which are a sort of collagen patch that integrates with the…
- Conditions
- Breast Implant; Complications, Breast Implant Infection, Implant Capsular Contracture, Breast Seroma
- Trial name
- RTADM (NCT06139588)
- Testing
- acellular dermal matrix implant for breast reconstruction
- Where
- Italy
- Volunteers
- 146 people
- Sponsor
- European Institute of Oncology
Breast Neoplasm
Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction
Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block.
- Trial name
- NCT02913573
- Testing
- Ultrasound, 0.25% bupivacaine
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Huntington Memorial Hospital
Breast Cancer
Preoperative Imaging in DIEP Flap Breast Reconstruction
The purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast…
- Trial name
- NCT02111239
- Testing
- CTA, MRA
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- Sunnybrook Health Sciences Centre
Breast Reconstruction, Breast Augmentation
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- NCT00753922
- Testing
- Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
- Where
- United States
- Volunteers
- 1,008 people
- Sponsor
- Mentor Worldwide, LLC
Breast Cancer, Necrosis
Novel Application of Indocyanine Green as a Biomarker to Identify Tissue Necrosis in Mastectomy Patients
Breast reconstruction is a common procedure that can dramatically improve the quality of life and satisfaction for women who undergo mastectomy, with over 100,000 procedures performed in the U.S. in 2018.
- Trial name
- NCT04145323
- Testing
- ICG microangiography
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Wisconsin, Madison
Breast Surgery
Efficacy of Written Versus Video Patient Education Materials for Postmastectomy Breast Reconstruction
This is a prospective, randomized controlled trial evaluating the comparative efficacy of written, video, and combined written and video patient education materials relative to no supplemental education for University of…
- Trial name
- NCT07602374
- Testing
- Questionnaires, Video Health Education Materials, Written Health Education Materials
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, San Francisco
Breast Cancer
Impact of Radiotherapy on Patients Undergoing DIEP Flap Breast Reconstruction
The investigators intend to undertake a study to investigate the effect of radiotherapy on deep inferior epigastric perforator flap reconstructions (DIEP).
- Trial name
- NCT03072316
- Testing
- 3D surface imaging, semi-structured interview, applanation tonometry
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Disease, Breast Cancer
Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.
The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR).
- Conditions
- Breast Disease, Breast Cancer, Patient Satisfaction, Surgery
- Trial name
- PROM-Q (NCT04842240)
- Testing
- Pre- or sub-pectoral implant based immediate breast reconstruction
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Lymphedema, Lymphedema of Upper Arm
Microvascular Breast Reconstruction With Lymph Node Transfer
this study aims to evaluate the outcomes of simultaneous free abdominal flap \& vascularized lymph node transfer for both breast reconstruction and postmastectomy lymphedema
- Conditions
- Lymphedema, Lymphedema of Upper Arm, Mastectomy; Lymphedema
- Trial name
- NCT04246034
- Testing
- Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer
- Sponsor
- Assiut University
Breast Cancer
Autologous vs. Implant-based Breast Reconstruction
Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective.
- Trial name
- GoBreast II (NCT06195865)
- Testing
- DIEP-flap, Implant
- Where
- 2 sites in Sweden
- Volunteers
- 250 people
- Sponsor
- Vastra Gotaland Region
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
Post Operative Pain
The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing reduction mammoplasty.
- Trial name
- NCT05901116
- Testing
- Serratus posterior superior intercostal plane block (SPSIPB)
- Where
- Turkey (Türkiye)
- Volunteers
- 10 people
- Sponsor
- Cumhuriyet University
Breast Cancer
Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
The purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients.
- Trial name
- NCT03743324
- Testing
- Immediate Breast reconstruction, Delayed Breast Reconstruction, Radiation
- Volunteers
- 1,344 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Complications, Postoperative/Perioperative, Quality of Life
Complications and Long-term Satisfaction in Autologous vs. Implant-Based Breast Reconstruction
Current literature on complications and health-related quality of life in autologous and alloplastic breast reconstruction is inconclusive.
- Conditions
- Complications, Postoperative/Perioperative, Quality of Life, Satisfaction, Patient
- Trial name
- NCT06295042
- Testing
- BREAST-Q Questionnaire
- Where
- Austria
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz