Clinical trials: Mastectomy and Breast Reconstruction
Breast Carcinoma, Breast Reconstruction
Prepectoral and Subpectoral Implant-based Breast Reconstruction
Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase…
- Trial name
- NCT04688697
- Testing
- prepectoral implant-based reconstruction, subpectoral implant-based reconstruction
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Fudan University
Breast Cancer
The Combination of PECS II Block and Parasternal Block for Radical Mastectomy
The combination of PECS II and parasternal Block provides analgesia after radical mastectomy
- Trial name
- NCT03754816
- Testing
- PECS II and parasternal block, Levobupivacaine
- Where
- Italy
- Volunteers
- 65 people
- Sponsor
- San Salvatore Hospital of L'Aquila
Breast Cancer Classified as TNM Stage 0-IIIa
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
Research Purpose The present study is designed to generate the strongest evidence available on the role of robotic surgical systems in breast cancer surgery and to elucidate the clinical value of immediate breast reconstruction…
- Trial name
- ROM (NCT05490433)
- Testing
- Robot-assisted Nipple-Sparing Mastectomy (RNSM), Conventional nipple sparing mastectomy(CNSM)
- Where
- 17 sites in South Korea
- Volunteers
- 790 people
- Sponsor
- Yonsei University
Breast Reconstruction
Pilot Study Assessing Breast Temperature in Breast Cancer Patients
Our investigators plan to measure the skin on the breast six months after breast reconstruction. The non-reconstructed breast will be used as the control for subject with unilateral reconstruction only.
- Trial name
- NCT03376035
- Testing
- Temperature measurement of breast
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Duke University
Breast Cancer
Radiotherapy After Mastectomy for Breast Cancer Patients at Increased Risk of Local Recurrence
STUDY DESCRIPTION: This is a single-arm study to assess the feasibility, toxicity and cosmetic outcome of partial radiotherapy of the chest wall in breast cancer patients at increased risk of local relapse submitted to…
- Trial name
- NCT03101683
- Testing
- Partial chest wall radiation therapy
- Volunteers
- 28 people
- Sponsor
- Fondazione del Piemonte per l'Oncologia
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
Breast Cancer
Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy
Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as…
- Trial name
- NCT06119633
- Testing
- Immediate tissue expander and lipofilling after mastectomy
- Where
- 2 sites in Italy
- Volunteers
- 163 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Breast Cancer
The Effect of Digital Technology-Supported Education on Patients Undergoing Breast Reconstruction After Mastectomy: A Randomized Controlled Study
The goal of this randomized, controlled study is to test the effectiveness of digital technology-supported education on patients undergoing breast reconstruction after mastectomy.
- Trial name
- NCT06166953
- Testing
- digital technology-supported education
- Where
- Turkey (Türkiye)
- Volunteers
- 38 people
- Sponsor
- Baskent University
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
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
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
Skin Necrosis, Breast Reconstruction
B4P Trial - BLOOM43 for Preconditioning
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer.
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Trial name
- NCT07340632
- Testing
- BLOOM43
- Volunteers
- 60 people
- Sponsor
- Plexaa Ltd
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
Breast Cancer
Breast Reconstruction and Radiotherapy
If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy.
- Trial name
- CONRAD (NCT07178886)
- Where
- Netherlands
- Volunteers
- 750 people
- Sponsor
- Janine M. Simons MD PhD
Breast Cancer
The Effects of Indocyanine Green Angiography (IGA) on Deep Inferior Epigastric Artery Perforator (DIEP) Flap Design and Post-Operative Fat Necrosis
The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast…
- Trial name
- SPY (NCT02144961)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Washington
Breast Cancer Female, Breast Reconstruction
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).
- Trial name
- SCderm (NCT06555692)
- Testing
- Transplant acellular dermal matrix(ADM)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- DOF Inc.
Capsular Contracture Associated With Implant, Foreign-Body Reaction
Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis
The goal of this single-center, randomised double-blinded trial is to compare the early stage fibrosis progression around conventional textured expander and the SmoothSilk® expander with reduced surface roughness in women…
- Conditions
- Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries, Tissue Expander Disorder
- Trial name
- NCT05648929
- Testing
- Patient Satisfaction Questionnaire, Pregnancy test, Blood draw
- Where
- Austria
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck
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 Cancer
Post-op Outcomes of Enhanced Energy Delivery Dissection for Mastectomy With Immediate Breast Reconstruction
Principal Investigator: Sheldon Feldman, MD Co-Principal Investigator: Mohamad Sebai, MD Department of Surgery, Montefiore Medical Center - Einstein College of Medicine Title Pilot Study: Post-operative outcomes of enhanced…
- Trial name
- NCT03627442
- Testing
- Mastectomy with PhotonBlade, Mastectomy with Bovie
- Volunteers
- 15 people
- Sponsor
- Invuity, Inc.
Breast Cancer, Breast Neoplasms, Breast Reconstruction
Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction
Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Reconstruction, DIEP Flap Breast Reconstruction, Robotic Surgery
- Trial name
- REBORN (NCT07230535)
- Testing
- Robotic Assisted Nipple Sparing Mastectomy, Standarding Open Nipple Sparing Mastectomy
- Where
- Ireland
- Volunteers
- 250 people
- Sponsor
- Beaumont Hospital