Clinical trials: Prepectoral Breast Reconstruction
Mastectomy; Lymphedema, Breast Cancer
Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy
The purpose of this multicenter retrospective cohort study is to determine the effect of radiotherapy on capsular contraction and implant loss rates in patients undergoing prepectoral immediate implant-based breast reconstruction…
- Trial name
- PRExRT (NCT06747065)
- Testing
- Radiotherapy
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Basel, Switzerland
Breast Reconstruction
Comparing Two Different Surgical Techniques for Breast Reconstruction
The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique.
- Trial name
- NCT04716959
- Testing
- Prepectoral Prosthetic Breast Reconstruction, Subpectoral Prosthetic Breast Reconstruction
- Where
- 7 sites in United States
- Sponsor
- Memorial Sloan Kettering Cancer Center
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 Cancer Female
Delayed Breast Reconstruction by Prepectoral Implant After Lipo-preparation (RM2prepec)
Breast implants associated with the installation of a complementary matrix (of dermal or synthetic origin), showed satisfactory results in term of post-operative follow-up but also aesthetic outcomes.
- Trial name
- RM2prepec (NCT04343820)
- Testing
- Breast reconstruction
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Institut Cancerologie de l'Ouest
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 Cancer, Breast Reconstruction
Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer
This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous…
- Conditions
- Breast Cancer, Breast Reconstruction, Coated Materials, Reconstruction Breast Surgery
- Trial name
- FluoropolyMesh (NCT07185334)
- Testing
- Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants., Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Saint Petersburg State University, Russia
Breast Cancer, Risk Reduction
Restore-B: A Trial Comparing Prepectoral Implant-based Breast Reconstruction With and Without Mesh
The goal of this feasibility randomised controlled clinical trial (RCT) is to compare mesh-assisted to no-mesh pre-pectoral implant based immediate breast reconstruction in women undergoing mastectomy for treatment of breast…
- Trial name
- NCT06112977
- Testing
- Prepectoral implant-based immediate breast reconstruction
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- University of Oxford
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
Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR
Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery…
- Trial name
- DRAIN (NCT07237828)
- Testing
- Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
- Where
- China
- Volunteers
- 379 people
- Sponsor
- Du Zhenggui
Stage II Breast Cancer, Stage I Breast Cancer
Comparison Between Prepectoral and Subpectoral Breast Reconstruction
There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction.
- Trial name
- RESPECT (NCT05833659)
- Testing
- The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Beijing Friendship Hospital
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
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 Patients
Efficacy and Safety of Prepectoral Prosthesis Immediate One-Stage Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer Patients: A Prospective, Single-Center, Cohort Study
Prospective Evaluation of the Efficacy and Safety of Prepectoral Immediate One-Stage Prosthetic Breast Reconstruction Versus Two-Stage Expander/Prosthesis Reconstruction in Postoperative Adjuvant Radiotherapy Breast Cancer…
- Trial name
- NCT07037576
- Testing
- Breast Reconstruction Surgery
- Where
- China
- Volunteers
- 104 people
- Sponsor
- Henan Cancer Hospital
Prepectoral Breast Reconstruction, Breast Reconstruction
Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes
The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants.
- Conditions
- Prepectoral Breast Reconstruction, Breast Reconstruction, Radiation Therapy Complication
- Trial name
- IBR-PPBR (NCT06216106)
- Testing
- Prepectoral breast reconstruction with polyurethane implants
- Where
- Italy
- Volunteers
- 237 people
- Sponsor
- European Institute of Oncology
Breast Reconstruction
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
- Trial name
- NCT06575192
- Testing
- ARTIA Reconstructive Tissue Matrix
- Where
- 23 sites in United States
- Volunteers
- 264 people
- Sponsor
- AbbVie
Breast Cancer
Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with…
- Trial name
- NCT07372339
- Testing
- Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction, Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
- Volunteers
- 170 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- Trial name
- NCT06823414
- Testing
- Video assisted mastectomy
- Where
- Spain
- Volunteers
- 126 people
- Sponsor
- Alejandra García-Novoa
Prepectoral Breast Reconstruction, TiLOOP Mesh
Pre-pectoral Breast Reconstruction With or Without Mesh
To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.
- Trial name
- NCT05888571
- Testing
- prepectoral breast reconstruction, Tiloop Mesh implantation
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
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
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